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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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Easy Lab Pro RSV - 10694644700036

Easy Lab Pro RSV - US
AMERICAN BIO MEDICA CORPORATION
10-RSV-ELP
In Commercial Distribution

  • 10694644750031 ()
  • 10694644700036 ()
10-RSV-ELP

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator

RDS - 10694644700029

RSV Test Kit European 135065
AMERICAN BIO MEDICA CORPORATION
10-RSV-065
In Commercial Distribution

  • 10694644700029 ()
  • 10694644750024 ()
10-RSV-065

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator

RDS - 10694644700012

RSV Test Kit US Version 135060
AMERICAN BIO MEDICA CORPORATION
10-RSV-060
In Commercial Distribution

  • 10694644700012 ()
  • 10694644750017 ()
10-RSV-060

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator

NoFact IX - 10859394006160

Factor IX immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
69-201
In Commercial Distribution

  • 10859394006160 ()
  • 00859394006163 ()
69-201

  • Coagulation factor IX IVD, kit, clotting

HemosIL Factor IX Deficient Plasma (10 X 1 mL) - 08426950478553

HemosIL Factor IX Deficient Plasma (10 X 1 mL)
INSTRUMENTATION LABORATORY COMPANY
00020011900
In Commercial Distribution

  • 08426950478553 ()
  • 18426950478550 ()
00020011900

  • Coagulation factor IX IVD, kit, clotting

Prolex Group B Streptococcal Xtra Latex Reagent - 10628429001339

Group B Latex Reagent
PRO-LAB, INCORPORATED
PL.1032
In Commercial Distribution

  • 10628429001339 ()
PL.1032

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent

Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System - B110IB21120

No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution

  • B110IB21120 ()
IB-2112

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

TriniCLOT™ Factor IX - 15391521420418

No Description
TCOAG IRELAND LIMITED
T1509
In Commercial Distribution

  • 15391521420418 ()
  • 05391521420411 ()


  • Coagulation factor IX IVD, kit, clotting

NeuMoDxTM GBS Test Strip - 10814278020045

NeuMoDx GBS Test Strip
Neumodx Molecular, Inc.
200400
Not in Commercial Distribution

  • 10814278020045 ()
  • 00814278020048 ()
200400

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent

C. DIFF CHEK - 60 - 00857031002233

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with patient history.
TECHLAB, INC.
T5025B
In Commercial Distribution

  • 00857031002233 ()


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