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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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QuickVue - 30014613003540

Strep A Liquid Ctrl
QUIDEL CORPORATION
00354
In Commercial Distribution

  • 30014613003540 ()
00354

  • Beta-haemolytic Group A Streptococcus antigen IVD, control

QuickVue In-Line - 30014613003458

QkVue InLine Strep A Ctrl Set
QUIDEL CORPORATION
00345
In Commercial Distribution

  • 30014613003458 ()
00345

  • Beta-haemolytic Group A Streptococcus antigen IVD, control

Rabbit Monoclonal Anti-Human IgA (Heavy Chain) Antibody, EP170 - 00810113063867

Rabbit Monoclonal Anti-Human IgA (170), concentrated
Epitomics Inc.
AC-0147BULK
In Commercial Distribution

  • 00810113063867 ()


  • Total immunoglobulin A (IgA total) IVD, antibody

Rabbit Monoclonal Anti-Human IgA (Heavy Chain) Antibody, EP170 - 00810113063843

Rabbit Monoclonal Anti-Human IgA (170), 1 mL concentrated
Epitomics Inc.
AC-0147
In Commercial Distribution

  • 00810113063843 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody

Rabbit Monoclonal Anti-Human IgA (Heavy Chain) Antibody, EP170 - 00810113063836

Rabbit Monoclonal Anti-Human IgA (170), 0.5 mL concentrated
Epitomics Inc.
AC-0147B
In Commercial Distribution

  • 00810113063836 ()

  • Total Volume: 0.5 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody

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

OSOM ULTRA PLUS FLU A&B Control Kit - 00742860100406

No Description
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution

  • 10742860100403 ()
  • 00742860100406 ()


  • Influenza A/B virus antigen IVD, control
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