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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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No Description
CELL MARQUE CORPORATION
760-4384
In Commercial Distribution

  • 00841683100805 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
760-2652
In Commercial Distribution

  • 00841683100188 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
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
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


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

  • 08056771100205 ()


  • Hepatitis A virus total antibody IVD, control
Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
Alere Scarborough, Inc.
575-080
In Commercial Distribution

  • 10811877010989 ()


  • Influenza A/B virus antigen IVD, control
The Control Swabs are intended for use only with the Alere Influenza A & B Test.
Alere Scarborough, Inc.
412-080
Not in Commercial Distribution

  • 10811877010880 ()


  • Influenza A/B virus antigen IVD, control
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
Immunoglobulin A 360 Tests
ABBOTT IRELAND
09P6124
In Commercial Distribution

  • 00380740171711 ()
09P6124

  • Adenovirus immunoglobulin A (IgA) antibody IVD, reagent
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