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CARTRIDGE 402-02 ACT RACT 13 LAN
MEDTRONIC, INC.
402-02
Not in Commercial Distribution
- 20613994417286 ()
- 00613994417282 ()
- Heparin anti-Xa IVD, kit, chromogenic
Protective Paper Covers
Premium Plus International Limited
178-2
In Commercial Distribution
- D83817822 ()
- D83817820 ()
- X-ray film storage envelope
Protective Paper Covers
Premium Plus International Limited
178-1
In Commercial Distribution
- D83817812 ()
- D83817810 ()
- X-ray film storage envelope
Protective Paper Covers
Premium Plus International Limited
178-0
In Commercial Distribution
- D83817802 ()
- D83817800 ()
- X-ray film storage envelope
In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.
Siemens Healthcare Diagnostics Products GmbH
10873681
In Commercial Distribution
- 00630414240404 ()
OPPU05
- Coagulation factor Xa inhibitor/heparin activity reagent kit IVD
Sterilization Wrap, Single Sheet, Purple, V300, 45 X 45
Vivit Supply LLC
345SL
In Commercial Distribution
- 20810141932887 ()
- 10810141932880 ()
- 00810141932883 ()
- Sterilization packaging, single-use
No Description
Precision Biologic Inc
FDP10-15
In Commercial Distribution
- 00843876000336 ()
- 00843876010335 ()
- Multiple coagulation factor IVD, reagent
- Coagulation factor X IVD, reagent
No Description
Precision Biologic Inc
FDP10-10
In Commercial Distribution
- 00843876000329 ()
- 00843876010328 ()
- Multiple coagulation factor IVD, reagent
- Coagulation factor X IVD, reagent
The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,
and software that captures images of in vivo tissue specimens from the exposed surface of the
tissue, through the unstained epithelium and into the superficial supporting stroma. It provides
non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System
does NOT provide automated analysis or diagnosis of the images it produces. It is capable of
imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the
dermis. In addition, it is possible to visualize circulation of blood cells (including both
erythrocytes and leukocytes) in capillaries and other small vessels.
Caliber Imaging & Diagnostics, Inc.
1500, 3000, or both
In Commercial Distribution
- 00860292000306 ()
- Scanning laser optical microscope
Autoloader w/EBR- GCS3000Dx
Affymetrix, Inc.
00-0146
In Commercial Distribution
- 00856826006043 ()
00-0146
- Scanning laser optical microscope
The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,
and software that captures images of in vivo tissue specimens from the exposed surface of the
tissue, through the unstained epithelium and into the superficial supporting stroma. It provides
non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System
does NOT provide automated analysis or diagnosis of the images it produces. It is capable of
imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the
dermis. In addition, it is possible to visualize circulation of blood cells (including both
erythrocytes and leukocytes) in capillaries and other small vessels.
Caliber Imaging & Diagnostics, Inc.
1500, 3000, or both
In Commercial Distribution
- 08602920003066 ()
- Scanning laser optical microscope
The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phase contrast) mode, or in fluorescence mode for specimens that are stained with fluorochromes that fluoresce when illuminated with a laser. The VivaScope 2500 is used by physicians and other licensed healthcare professionals to view enlarged images of specimens during pathological examinations.
Caliber Imaging & Diagnostics, Inc.
2500
In Commercial Distribution
- 08602920003035 ()
- Scanning laser optical microscope
No Description
VISIA LAB SRL
dIFine Automated Microscope
In Commercial Distribution
- 08059304340109 ()
- Scanning laser optical microscope
Brand Name: cCeLL
Device Name: cCeLL - Ex vivo
Model Name:CX100-1W1C488
VPIX Medical, Inc.
CX100-1W1C488
In Commercial Distribution
- 08800112400215 ()
- Scanning laser optical microscope
Brand Name: cCeLL
Device Name: cCeLL - Ex vivo
Model Name:CX100-2W2C488775
VPIX Medical, Inc.
CX100-2W2C488775
In Commercial Distribution
- 08800112400192 ()
- Scanning laser optical microscope
No Description
Carl Zeiss Meditec AG
6918
In Commercial Distribution
- 04049539069184 ()
- Scanning laser optical microscope
Sterilization Wrap,Double Layer Two Color,Purple & Blue,V300,54 X 90
Vivit Supply LLC
590DL
In Commercial Distribution
- 20810141933198 ()
- 10810141933191 ()
- 00810141933194 ()
- Sterilization packaging, single-use
Sterilization Wrap,Double Layer Two Color,Purple & Blue,V500,36 X 36
Vivit Supply LLC
536DL
In Commercial Distribution
- 20810141933181 ()
- 10810141933184 ()
- 00810141933187 ()
- Sterilization packaging, single-use
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution
- 00858352006009 ()
H9200
- Multiple blood group genotyping IVD, control
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles
encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution
- 08437013457040 ()
1301790000
- Multiple blood group genotyping IVD, control
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology.
The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution
- 08437013457019 ()
1021720000
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution
- 10888234102632 ()
800-20236
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution
- 10888234102618 ()
800-20202-96
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution
- 10888234102328 ()
800-00229
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution
- 10888234102298 ()
800-00228
- Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution
- 10888234100065 ()
800-20202-08
- Multiple blood group genotyping IVD, nucleic acid technique (NAT)
Tinted Liquid
JBC and Company
X
In Commercial Distribution
- D851X0 ()
X
- Dental appliance fabrication material, resin
No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution
- 10888234100928 ()
800-10242
- Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution
- 10888234100836 ()
800-00287
- Multiple blood group genotyping IVD, reagent
No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution
- 10888234100683 ()
800-00195
- Multiple blood group genotyping IVD, reagent