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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
SEKISUI DIAGNOSTICS, LLC
147
In Commercial Distribution

  • 00742860001475 ()
  • 10742860001472 ()
147

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
141
In Commercial Distribution

  • 00742860001413 ()
  • 10742860001410 ()
141

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
PRO ADVANTAGE A 25/BX
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080033
In Commercial Distribution

  • M220P0800335 ()
  • M220P0800333 ()
P080033

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
XL-A1C2-30
In Commercial Distribution

  • 00817274021774 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
A1C2-30
In Commercial Distribution

  • 00817274021767 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b
DREW SCIENTIFIC, INC.
A1C2-30A
In Commercial Distribution

  • 00817274021750 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1029
Not in Commercial Distribution

  • B350GSD0110290 ()
GSD01-1029

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Biomet Orthopedics, LLC
32-360001
In Commercial Distribution

  • 00880304530386 ()

  • TYPE A, SMALL
32-360001

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-360002
In Commercial Distribution

  • 00880304529922 ()

  • TYPE A, MEDIUM
32-360002

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-360000
In Commercial Distribution

  • 00880304529878 ()

  • TYPE A, X-SMALL
32-360000

  • Knee tibia prosthesis trial, reusable
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