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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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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, 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
GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL
Bio-RAD Laboratories, Inc.
26220
In Commercial Distribution

  • 00847865013185 ()

  • Total Volume: 1.5 Milliliter
26220

  • HIV1/HIV2 antigen/antibody IVD, control
GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26223
In Commercial Distribution

  • 00847865010672 ()

  • Total Volume: 1.5 Milliliter
26223

  • HIV1/HIV2 antigen/antibody IVD, control
MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests
Bio-RAD Laboratories, Inc.
25228
Not in Commercial Distribution

  • 00847865002745 ()

  • 50 Tests
25228

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Refurbished COBE® Spectra Apheresis System
TERUMO BCT, INC.
71900
Not in Commercial Distribution

  • 05020583719002 ()


  • Blood transfer set
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
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, 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, 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
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