SEARCH RESULTS FOR: (*Boise State University本科成绩单<网址:ｚｊｗ２１１.ｃｏｍ>白银Natsional*)(4472 results)
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.
Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
Tem Innovations GmbH
sigma complete + hep
In Commercial Distribution
- 04260160470600 ()
- 04260160470327 ()
555502
- Multiple coagulation factor IVD, kit, clotting
Compact, lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Lite
In Commercial Distribution
- B702P32C0 ()
P32C
- Stand-on floor scale, electronic
- Posturography system platform
- Posturography system
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution
- 04987669100530 ()
- Optical pachymeter
- Direct ophthalmoscope, line-powered
The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being.
The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body.
The Nova HD is intended to be operated and used by the same person.
The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Aura Wellness, LLC
Nova HD Starter Kit
In Commercial Distribution
- 00850026680065 ()
APN-00026
- Deep-tissue electromagnetic stimulation system, home-use
The Nova HD Pulsed Electronic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, The Aura is easy to operate and incorporates many features to promote human health and well-being.
The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body.
The Nova HD is intended to be operated and used by the same person.
The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Aura Wellness, LLC
Nova HD
In Commercial Distribution
- 00850026680003 ()
NOVA HD
- Deep-tissue electromagnetic stimulation system, home-use
Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution
- B702P31C0 ()
P31C
- Biomechanical function analysis/interactive rehabilitation system
- Posturography system
- Posturography system platform
- Stand-on floor scale, electronic
Kit Includes:
(T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider
(R138) Montana Jack™
(R223) 23 Explorer-12 Probe
(R245) Cone Socket Mirror Handle
(R269) 3-6 Discoid-Cleoid Carver
(R284) Hollenback 1/2-3 Carver
(R286) G2 Thin Composite
(R287) G3 Thin Composite
(R333) 27-29 Burnisher
(R336) Calcium Hydroxide Placer
(R347) 0-1 Blacks Plugger
(R362) 113 Off Angle Cord Packer
(R375) Mixing Spatula-Applicator
(R386) 38-39 Excavator
(R534) IPC-T Gold Line™ (Composite Sculpting System)
(T042) Meriam Tweezers
(T046) Miller Articulating Paper Forceps
(T050) #5 Mirror (15/16")
(T235) Aspirating Anesthetic Syringe Medium
(T356) Amalgam Well
(T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R937 PDT Total Restorative Kit
In Commercial Distribution
- 00813677024978 ()
R937
- Instrument tray, reusable
- Dental mirror, reusable
- Dental irrigation/aspiration syringe
- Manual dental scaler, reusable
- Dental surgical probe, reusable
- Manual non-rotary dental instrument handle
- Dental restoration carver, resin
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable
- Dental restoration carver, amalgam, reusable
- Manual dental burnisher, reusable
- Dental amalgam condenser, reusable
- Dental amalgam well
- Gingival retraction cord packing tool
- Dental spatula, reusable
- Dental excavator, reusable
- Suture scissors
The Televisit software is intended for the purposes of collecting physiological data such as: Non-Invasive Blood Pressure; Pulse Oximetry, Temperature and Breath Sounds (Auscultation), Spirometer, Glucometer and E.C.G.
The intended use of the Televisit software is in hospital/clinical environments with established specialized care providing access to each patient in their home and/or local community health center. Televisit software is a non-invasive medical device, which does not flag any abnormal results from the medical device inputs. The Televisit software does not monitor, assess or diagnose a disease, a disorder, or an abnormal physical state. The intended use for the software is data acquisition and collection only, with no treatment function or danger to the end user. The data obtained from Televisit software can be used only as an aid in the diagnosis and treatment of the patient.
Primonics (2006) Inc
TVS
In Commercial Distribution
- 00628250477016 ()
- Pulse oximeter, line-powered
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp.
Tem Innovations GmbH
star-tem® 20
In Commercial Distribution
- 04260160470099 ()
- 04260160470518 ()
503-10-US
- Multiple coagulation factor IVD, reagent
The Flight X-Vision Portable Handheld X-Ray is an ultra-safe state of the art system that has lower radiation levels than your traditional wall mounted x-rays. In addition, the ergonomic design allows the x-ray to be comfortably held in your hands and with one of the most intuitive and easy to use interfaces it makes doing a full mouth series even faster and more efficient. The X-Vision features the longest battery life on the market, with a full charge, it is able to take up to 800 shots with very low exposure times while producing the best quality images whether it’s on film, digital sensor or phosphorus plates. Finally, with the use of high quality components, from the Panasonic battery to the Toshiba tube head, made in Japan, the X-Vision is the workhorse X-Ray for every office.
Flight Dental Systems
XR-3800
In Commercial Distribution
- D884XR3800 ()
X-Vision
- Hand-held intraoral dental x-ray system, digital
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution
- 08719481550332 ()
- Biofeedback system application software
The NATtrol™ Enterovirus (EV) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Enterovirus Negative Control
In Commercial Distribution
- 01220000260177 ()
NATEVNEG-6MC-IVD
- Enterovirus nucleic acid (serotypes 68-71) IVD, control
The NATtrol™ Enterovirus (EV) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Enterovirus Positive Control
In Commercial Distribution
- 01220000260160 ()
NATEVPOS-6MC-IVD
- Enterovirus nucleic acid (serotypes 68-71) IVD, control
The NATtrol™ Norovirus Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Norovirus Negative Control
In Commercial Distribution
- 01220000260139 ()
NATROTA-6MC-IVD
- Norovirus nucleic acid IVD, control
The NATtrol™ RSV Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ RSV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ RSV Positive Control
In Commercial Distribution
- 01220000260092 ()
NATRSV-6C-IVD
- Respiratory syncytial virus (RSV) nucleic acid IVD, control
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710010
Not in Commercial Distribution
- M2697100101 ()
- 10381780114345 ()
- 10 cc
710010
- Bone matrix implant, composite
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710010
Not in Commercial Distribution
- 10381780112051 ()
- 10 cc
710010
- Bone matrix implant, composite
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710015
Not in Commercial Distribution
- M2697100151 ()
- 10381780114352 ()
- 15 cc
710015
- Bone matrix implant, composite
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710005
Not in Commercial Distribution
- M2697100051 ()
- 10381780114338 ()
- 5 cc
710005
- Bone matrix implant, composite
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710015
Not in Commercial Distribution
- 10381780112068 ()
- 15 cc
710015
- Bone matrix implant, composite
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages.
The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Integra Lifesciences Corporation
710005
Not in Commercial Distribution
- 10381780112044 ()
- 5 cc
710005
- Bone matrix implant, composite
"Methyl Green-Pyronin-Y Stain Solution is intended for used in differentiating DNA and RNA in tissue sections for the diagnosis of general pathology specimens. The reaction is based upon the competition between the slow staining, but doubly charged, methyl green and the more rapidly staining, singly charged pyronin Y.
Methyl green has two cationic charged groups that become linked to the phosphate moieties in the DNA. The pyronin Y displaces the methyl green from all sites of linkage except where its double charge gives it a selective advantage (acidic polymer such as DNA). Consequently, the methyl green stains DNA and retains its binding to this substance against the competitive action of pyronin Y. Pyronin Y stains the less polymerized RNA rapidly and displaces methyl green from linkages having smaller polymeric acidic substances (RNA). The reaction is done at pH 4.2 – pH 4.3. The advantage of a low pH is to have the nucleic acids in a charged condition and in their least soluble state."
RICHARD-ALLAN SCIENTIFIC COMPANY
Methyl Green-Pyronin Y Stain Solution
In Commercial Distribution
- 00673693089210 ()
87011
- Biological stain IVD
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary
whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSHBGM902) is intended to be used by a single person and should not be shared.
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH-BGM902
In Commercial Distribution
- 04719878121019 ()
- 34719878121010 ()
- 64719878121011 ()
- Glucose monitoring system IVD, home-use
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
Tem Innovations GmbH
hep-tem®
In Commercial Distribution
- 04260160470082 ()
- 04260160470501 ()
503-09-US
- Multiple coagulation factor IVD, reagent
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
Tem Innovations GmbH
in-tem®
In Commercial Distribution
- 04260160470044 ()
- 04260160470464 ()
503-02-US
- Multiple coagulation factor IVD, reagent
The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.
The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.
The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
MERIDIAN BIOSCIENCE, INC.
480350
In Commercial Distribution
- 00840733102196 ()
480350
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SARS-Related Coronavirus 2 Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ SARS-Related Coronavirus 2 Negative Control
In Commercial Distribution
- 01220000260375 ()
NATSARS(COV2)NEG1-IVD
- SARS-CoV-2 nucleic acid IVD, control
The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SARS-Related Coronavirus 2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ SARS-Related Coronavirus 2 Positive Control
In Commercial Distribution
- 01220000260368 ()
NATSARS(COV2)-ERC1-IVD
- SARS-CoV-2 nucleic acid IVD, control
The NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SARS-Related Coronavirus 2 Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ SARS-Related Coronavirus 2 Negative Control
In Commercial Distribution
- 01220000260351 ()
NATSARS(COV2)-NEG-IVD
- SARS-CoV-2 nucleic acid IVD, control
The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SARS-Related Coronavirus 2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ SARS-Related Coronavirus 2 Positive Control
In Commercial Distribution
- 01220000260344 ()
NATSARS(COV2)-ERC-IVD
- SARS-CoV-2 nucleic acid IVD, control