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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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Control swabs intended for use only with Strep A product.
Alere Scarborough, Inc.
730-010
In Commercial Distribution

  • 10811877010446 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, control
Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
Alere Scarborough, Inc.
575-080
Not in Commercial Distribution

  • 10811877010194 ()


  • Influenza A/B virus antigen IVD, control
No Description
DIASORIN SPA
310201
In Commercial Distribution

  • 08056771100205 ()


  • Hepatitis A virus total antibody IVD, control
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3913
Not in Commercial Distribution

  • 00840487101360 ()
3913

  • Influenza A virus nucleic acid IVD, reagent
VITROS Immunodiagnostic Products Anti-HAV Total Controls
ORTHO CLINICAL DIAGNOSTICS
6801463
In Commercial Distribution

  • 10758750001293 ()
6801463

  • Hepatitis A virus total antibody IVD, control
No Description
THE BINDING SITE GROUP LIMITED
MA010
In Commercial Distribution

  • 05051700020329 ()


  • Total immunoglobulin A (IgA total) IVD, reagent
No Description
THE BINDING SITE GROUP LIMITED
NQ624.OPT
In Commercial Distribution

  • 05051700019439 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ623.OPT
In Commercial Distribution

  • 05051700019422 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ087.OPT
In Commercial Distribution

  • 05051700019330 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ088.OPT
In Commercial Distribution

  • 05051700019262 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
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