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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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Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody - 00841683100805

No Description
CELL MARQUE CORPORATION
760-4384
In Commercial Distribution

  • 00841683100805 ()


  • Coagulation factor XIII A subunit IVD, antibody

IgA Rabbit Polyclonal Antibody - 00841683100188

No Description
CELL MARQUE CORPORATION
760-2652
In Commercial Distribution

  • 00841683100188 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody

MultiCode® Influenza A Primers - 00840487101360

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

RAMP® Flu A + B Control Swabs - 10627966005190

No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control

LIAISON® Control anti-HAV - 08056771100205

No Description
DIASORIN SPA
310201
In Commercial Distribution

  • 08056771100205 ()


  • Hepatitis A virus total antibody IVD, control

BinaxNOW Influenza A & B Card 2 Control Swab Kit - 10811877010989

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

Alere Influenza A & B Control Swab Kit - 10811877010880

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

BinaxNOW Strep A Control Swab Pack - 10811877010446

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

Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit - 10811877010194

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

Alinity - 00380740171711

Immunoglobulin A 360 Tests
ABBOTT IRELAND
09P6124
In Commercial Distribution

  • 00380740171711 ()
09P6124

  • Adenovirus immunoglobulin A (IgA) antibody IVD, reagent
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