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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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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

ARCHITECT - 00380740171704

Immunoglobulin A 372 tests
ABBOTT IRELAND
09D9824
In Commercial Distribution

  • 00380740171704 ()
09D9824

  • Adenovirus immunoglobulin A (IgA) antibody IVD, reagent

IHC - 00810170553455

No Description
Slmp, LLC
(BTO) Sample IgA Antibody (2ml)
In Commercial Distribution

  • 00810170553455 ()
SAM-RP07-2

  • Total immunoglobulin A (IgA total) IVD, antibody

IHC - 00810170550119

IgA Antibody with FITC Tag (1ml)
Slmp, LLC
IgA Antibody with FITC Tag (1ml)
In Commercial Distribution

  • 00810170550119 ()
FITC-007-01

  • Total immunoglobulin A (IgA total) IVD, antibody

Azur Pure Helical - 00810170018787

Azur
MICROVENTION INC.
45-051514
In Commercial Distribution

  • 10810170018784 ()
  • 00810170018787 ()

  • 15 mm x 14 cm
45-051514

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator

Azur Pure Helical - 00810170018770

Azur
MICROVENTION INC.
45-051014
In Commercial Distribution

  • 10810170018777 ()
  • 00810170018770 ()

  • 10 mm x 14 cm
45-051014

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator

Azur Pure Helical - 00810170018763

Azur
MICROVENTION INC.
45-051010
In Commercial Distribution

  • 10810170018760 ()
  • 00810170018763 ()

  • 10 mm x 10 cm
45-051010

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
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