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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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DIAGNOSTICA STAGO
00943
In Commercial Distribution

  • 03607450009439 ()


  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)
VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
BIOMERIEUX SA
30125-01
In Commercial Distribution

  • 03573026444204 ()


  • Clostridium difficile antigen IVD, antibody
The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
BIOMERIEUX SA
30118-01
In Commercial Distribution

  • 03573026229146 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
96 Test enzyme immunoassay kit for the determination of FIX Antigen
Affinity Biologicals Inc
FIX-AG
In Commercial Distribution



  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0105
In Commercial Distribution

  • 00816784020628 ()

  • Total Volume: 20 Milliliter
2020-0105

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0104
In Commercial Distribution

  • 00816784020611 ()

  • Total Volume: 5 Milliliter
2020-0104

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56150 ()
BSB 5615

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56140 ()
BSB 5614

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56130 ()
BSB 5613

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56120 ()
BSB 5612

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
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