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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Biosafe S.A.
CryoSC-Db Seal positioner
In Commercial Distribution

  • 07640125650570 ()
7035

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
CryoSC-D Seal positioner
Not in Commercial Distribution

  • 07640125650563 ()
7026

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Insertion Tool
Not in Commercial Distribution

  • 07640125650556 ()
  • 07640125650648 ()
7030

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Metal Storage Canister
In Commercial Distribution

  • 07640125650549 ()
  • 07640125650532 ()
  • 07640125650631 ()
7012

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Overwrap Bag
In Commercial Distribution

  • 07640125650518 ()
  • 07640125650525 ()
4085

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Traceability Labels for Bioarchive
Not in Commercial Distribution

  • 07640125650501 ()
7031

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Traceability Labels for cryopreservation
Not in Commercial Distribution

  • 07640125650495 ()
7011

  • Blood centrifugation system containment kit
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007514
In Commercial Distribution

  • 10628451188268 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007521
In Commercial Distribution

  • 10628451188251 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007538
In Commercial Distribution

  • 10628451188244 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
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