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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
Roche Molecular Systems, Inc.
09040536190
In Commercial Distribution

  • 00875197006483 ()
09040536190

  • HIV1/HIV2 nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
09040528190
In Commercial Distribution

  • 00875197006384 ()
09040528190

  • HIV1/HIV2 nucleic acid IVD, control
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL
Bio-RAD Laboratories, Inc.
26166
Not in Commercial Distribution

  • 00847865018456 ()

  • Total Volume: 1 Milliliter
26166

  • HIV1/HIV2 antibody IVD, reagent
GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL
Bio-RAD Laboratories, Inc.
26228
In Commercial Distribution

  • 00847865013253 ()

  • Total Volume: 40 Milliliter
26228

  • HIV1/HIV2 antigen/antibody IVD, reagent
GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL
Bio-RAD Laboratories, Inc.
26227
In Commercial Distribution

  • 00847865013246 ()

  • Total Volume: 40 Milliliter
26227

  • HIV1/HIV2 antigen/antibody IVD, reagent
GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL
Bio-RAD Laboratories, Inc.
26226
In Commercial Distribution

  • 00847865013239 ()

  • Total Volume: 18 Milliliter
26226

  • HIV1/HIV2 antigen/antibody IVD, reagent
GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL
Bio-RAD Laboratories, Inc.
26225
In Commercial Distribution

  • 00847865013222 ()

  • Total Volume: 10 Milliliter
26225

  • HIV1/HIV2 antigen/antibody IVD, reagent
GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL
Bio-RAD Laboratories, Inc.
26224
In Commercial Distribution

  • 00847865013215 ()

  • Total Volume: 1.7 Milliliter
26224

  • HIV1/HIV2 antigen/antibody IVD, calibrator
GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26222
In Commercial Distribution

  • 00847865013208 ()

  • Total Volume: 1.5 Milliliter
26222

  • HIV1/HIV2 antigen/antibody IVD, control
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