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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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Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1 Positive Control
In Commercial Distribution

  • 00850032683012 ()


  • HIV1 nucleic acid IVD, control
Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1/HCV/HBV Negative Control
In Commercial Distribution

  • 00850032683005 ()


  • PCR/NAT negative control IVD
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, 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
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 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
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