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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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PREMIER Toxins A and B - 00840733101694

Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD).
MERIDIAN BIOSCIENCE, INC.
616096
In Commercial Distribution

  • 00840733101694 ()
616096

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

VIDAS® C. difficile GDH - 03573026444204

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

VIDAS® C. difficile Toxin A & B - 03573026229146

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)

Asserachrom® IX:Ag - 03607450009439

No Description
DIAGNOSTICA STAGO
00943
In Commercial Distribution

  • 03607450009439 ()


  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)

ACCURUN® - 00816784020628

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® - 00816784020611

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

VisuLize Factor FIX Antigen Kit - 10629009020009

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)

Tinto Hepatitis B Virus Core Antigen RPab - B502BSB56150

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

Tinto Hepatitis B Virus Core Antigen RPab - B502BSB56140

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

Tinto Hepatitis B Virus Core Antigen RPab - B502BSB56130

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
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