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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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Seraclone® Anti-E (RH3) - 07611969950430

Blood Grouping Reagent Anti-E (RH3); Seraclone® Human Monoclonal (MS260/MS12); for tube test; 5ml
Bio-Rad Medical Diagnostics GmbH
802336100
In Commercial Distribution

  • 07611969950430 ()
802336100

  • Anti-E [RH003] red blood cell grouping IVD, antibody

IgE/FITC (Polyclonal) - B502BSB301110

IgE/FITC is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative
BIO SB, INC.
BSB-3011-1
In Commercial Distribution

  • B502BSB301110 ()

  • Total Volume: 1 Milliliter
BSB-3011-1

  • Immunoglobulin E subclass (IgE subclass) IVD, antibody

Curian Shiga Toxin - 00840733103308

The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.
MERIDIAN BIOSCIENCE, INC.
760630
In Commercial Distribution

  • 00840733103308 ()
760630

  • Escherichia coli antigen IVD, kit, fluorescent immunoassay

DG Gel 8 Anti-e - 08437014205145

For the determination of human e antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210124
Not in Commercial Distribution

  • 08437014205145 ()
210124

  • Anti-E [RH005] red blood cell grouping IVD, antibody

DG Gel 8 Anti-E - 08437014205121

For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210122
Not in Commercial Distribution

  • 08437014205121 ()
210122

  • Anti-E [RH003] red blood cell grouping IVD, antibody

MTS - 10758750005925

MTS Anti-e (small e) (Monoclonal) Card
MICRO TYPING SYSTEMS, INC
MTS080312
In Commercial Distribution

  • 10758750005925 ()
MTS080312

  • Anti-E [RH005] red blood cell grouping IVD, antibody

MTS - 10758750005901

MTS Anti-E (Monoclonal) Card
MICRO TYPING SYSTEMS, INC
MTS080212
In Commercial Distribution

  • 10758750005901 ()
MTS080212

  • Anti-E [RH003] red blood cell grouping IVD, antibody

BIOCLONE - 10758750003297

ANTI-SMALL E (ANTI-RH5) (MONOCLONAL) BIOCLONE 1X5ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
714180
In Commercial Distribution

  • 10758750003297 ()
714180

  • Anti-E [RH005] red blood cell grouping IVD, antibody

BIOCLONE - 10758750003259

ANTI-E (ANTI-RH3) (MONOCLONAL) BIOCLONE 1X5ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
713180
In Commercial Distribution

  • 10758750003259 ()
713180

  • Anti-E [RH003] red blood cell grouping IVD, antibody

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) - 23661562173192

Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems
DIAGAST
17319
In Commercial Distribution

  • 23661562173192 ()
17319

  • Anti-E [RH005] red blood cell grouping IVD, antibody
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