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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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Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
Not in Commercial Distribution

  • 10811877010293 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
HIV combi PT Elecsys cobas e 100
Roche Diagnostics GmbH
05390095160
In Commercial Distribution

  • 04015630942497 ()
05390095160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
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
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