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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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Millennium - 00190776193362

Middle Arm for Modified Kbel Retractor
Avalign Technologies, Inc.
63-246173
In Commercial Distribution

  • 00190776193362 ()


  • A/B transferase IVD, calibrator

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

NeuMoDxTM GBS Test Strip - 10814278020045

NeuMoDx GBS Test Strip
Neumodx Molecular, Inc.
200400
In Commercial Distribution

  • 10814278020045 ()
  • 00814278020048 ()
200400

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

CRYOcheck Chromogenic Factor IX - 00843876000565

CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use
Precision Biologic Inc
CCCF09
In Commercial Distribution

  • 00843876000565 ()
CCCF09

  • Coagulation factor IX IVD, kit, chromogenic

Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies - 04053252734557

Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution

  • 04053252734557 ()
3303

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus B Control Slides - 04053252729225

Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution

  • 04053252729225 ()
5075

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics™ Coxsackievirus A9 Monoclonal Antibody - 04053252672989

Coxsackievirus A9 Monoclonal Antibody
EMD Millipore Corporation
3301
Not in Commercial Distribution

  • 04053252672989 ()
3301

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackie Antibody Set - 04053252585258

Coxsackie Antibody Set
EMD Millipore Corporation
3350
Not in Commercial Distribution

  • 04053252585258 ()
3350

  • Coxsackie A/B virus antigen IVD, reagent
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