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TRANSCYTE® is a human fibroblast-derived temporary skin substitute
consisting of a polymer membrane and donated neonatal human
fibroblast cells cultured under aseptic conditions in vitro on a nylon
mesh. Prior to cell growth, this nylon mesh is coated with porcine
dermal collagen and bonded to a polymer membrane (silicone). This
membrane provides a transparent synthetic epidermis when applied.
As fibroblasts proliferate within the nylon mesh, they secrete human
dermal collagen, matrix proteins and growth factors. Following freezing,
no cellular metabolic activity remains; however, the tissue matrix and
bound growth factors are left intact. The human fibroblast-derived
temporary skin substitute provides a temporary protective barrier.
TRANSCYTE is transparent and allows direct visual monitoring of the
wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution
- 00618474000046 ()
- Skin regeneration template, human-/animal-derived
IntraSpin Fuse 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE110Z
In Commercial Distribution
- 00847236015831 ()
- Haematological concentrate system
IntraSpin Centrifuge, 220 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS220Z
In Commercial Distribution
- 00847236015824 ()
- Haematological concentrate system
IntraSpin Centrifuge, 110 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS110Z
In Commercial Distribution
- 00847236015817 ()
- Haematological concentrate system
SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory
ITL ASIA PACIFIC SDN. BHD.
A100756
In Commercial Distribution
- 19555240405613 ()
- 09555240405616 ()
A100756
- Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100752
Not in Commercial Distribution
- 19555240403862 ()
- 09555240403865 ()
A100752
- Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100750
In Commercial Distribution
- 19555240400731 ()
- 09555240400734 ()
A100750
- Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100740
In Commercial Distribution
- 19555240400533 ()
- 09555240400536 ()
A100740
- Blood/blood culture specimen transfer spike IVD, manual
CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995528
In Commercial Distribution
- 00630414598550 ()
10995528
- HIV1/HIV2 antigen/antibody IVD, control
ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution
- 00630414590202 ()
10697214
- HIV1/HIV2 antigen/antibody IVD, control
ADVIA Centaur® CHIV assay (100 tests)
Siemens Healthcare Diagnostics Inc.
10696880
In Commercial Distribution
- 00630414589749 ()
10696880
- HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution
- 00850025688826 ()
- Home pharmaceutical management support software
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution
- 00850025688819 ()
- Home pharmaceutical management support software
30ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530102-1
In Commercial Distribution
- 00850034511979 ()
- 00850034511962 ()
- Haematological concentrate system
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530101-1
In Commercial Distribution
- 00850034511955 ()
- 00850034511948 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution
- 00850034511832 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution
- 00850034511429 ()
- 00850034511597 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution
- 00850034511443 ()
- 00850034511580 ()
- Haematological concentrate system
30mL Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A30
In Commercial Distribution
- 00850034511559 ()
- 00850034511573 ()
- Haematological concentrate system
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A15
In Commercial Distribution
- 00850034511535 ()
- 00850034511566 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution
- 00850034511498 ()
- Haematological concentrate system
30mL Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A30
In Commercial Distribution
- 00850034511474 ()
- 00850034511450 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HDPRP30
In Commercial Distribution
- 00850034511405 ()
- 00850034511412 ()
- Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HDPRP15
In Commercial Distribution
- 10850034511310 ()
- 00850034511313 ()
- Haematological concentrate system
A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.
Bimini Technologies LLC
AMPLIFINE
In Commercial Distribution
- 00850034511887 ()
- 00850034511290 ()
- Haematological concentrate system preparation kit, platelet concentration
A sterile, single use, syringe assembly that is intended for separating and concentrating blood components along with the use of a desktop centrifuge. It enables blood to be separated and aspirated in a single device after they have been centrifuged.
Bimini Technologies LLC
GAAPS-25
In Commercial Distribution
- 00850034511900 ()
- 00850034511269 ()
- Haematological concentrate system preparation kit, platelet concentration
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A15
In Commercial Distribution
- 00850034511221 ()
- 00850034511214 ()
- Haematological concentrate system
Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution
- 05060508820031 ()
- Blood bank information system application software
ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution
- 05060496770066 ()
- Laboratory instrument/analyser application software IVD
The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.1
In Commercial Distribution
- 05060496770059 ()
- Blood bank information system application software
ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results of testing, assigns outcomes to individual samples according to a configured rule, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
BIOMEDICAL DATA SOLUTIONS LIMITED
2.0
In Commercial Distribution
- 05060496770028 ()
- Blood bank information system application software
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution
- 05060496770011 ()
- Blood bank information system application software
cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution
- 05060496770004 ()
- Blood bank information system application software
The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.
Chembio Diagnostic Systems Inc.
65-9502-0
In Commercial Distribution
- 00607158000083 ()
- HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9549-0
In Commercial Distribution
- 00607158000076 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9505-1
In Commercial Distribution
- 00607158000052 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described.
One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9552-0
In Commercial Distribution
- 00607158000045 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9546-0
In Commercial Distribution
- 00607158000038 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution
- 00607158000021 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
65-9500-0
In Commercial Distribution
- 00607158000007 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000421 ()
- Blood bank information system application software
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000414 ()
- Blood bank information system application software
The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.
IT SYNERGISTICS, LLC
2.0
In Commercial Distribution
- 00867268000407 ()
- Blood bank information system application software
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution
- 00866489000036 ()
740769
- Pipetting system
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
718463
In Commercial Distribution
- 00866489000012 ()
718463
- Electronic pipette
The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
30055067
In Commercial Distribution
- 00866489000005 ()
30055067
- Electronic pipette
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution
- 00866305000264 ()
- Length: 33 Centimeter
- Height: 9.9 Centimeter
- Width: 14.2 Centimeter
- Weight: 2.5 Kilogram
480-RW-2607-02
- Laboratory tubing welder
The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution
- 00866305000219 ()
- Weight: 1.6 Kilogram
- Width: 9.1 Centimeter
- Length: 27.2 Centimeter
- Height: 5.9 Centimeter
480-B40-00-1245
- Laboratory tubing welder
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution
- 00866305000202 ()
- Weight: 2.5 Kilogram
- Width: 14.2 Centimeter
- Height: 9.9 Centimeter
- Length: 33 Centimeter
480-RW-2607-00
- Laboratory tubing welder
No Description
BOEKEL INDUSTRIES, INC.
301000
In Commercial Distribution
- 00863626000201 ()
- Cryopreserved blood/tissue thawing unit