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

  • B110IB21120 ()
IB-2112

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent
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
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
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
Group B Latex Reagent
PRO-LAB, INCORPORATED
PL.1032
In Commercial Distribution

  • 10628429001339 ()
PL.1032

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
Coxsackie A9/A24 Control Slide
EMD Millipore Corporation
50209
Not in Commercial Distribution

  • 04061841171737 ()
50209

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackie B Control Slide
EMD Millipore Corporation
50208
Not in Commercial Distribution

  • 04061841171218 ()
50208

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution

  • 04053252734557 ()
3303

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution

  • 04053252729225 ()
5075

  • Coxsackie A/B virus antigen IVD, reagent
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