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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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Tissue-Tek Genie® DUO - 00615233010131

anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8487-C010
In Commercial Distribution

  • 00615233010131 ()
8487-C010

  • p40 protein IVD, antibody
  • Napsin A IVD, antibody

Tissue-Tek Genie® DUO - 00615233010124

anti-p40 [BC28] / Napsin A [EP205] Antibody Cocktail, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8487-M100
In Commercial Distribution

  • 00615233010124 ()
8487-M100

  • p40 protein IVD, antibody
  • Napsin A IVD, antibody

Trinity Biotech - 05391516747998

Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent

Trinity Biotech - 05391516747936

Clostridium difficile Toxin Control, 1.0 mL
MARDX DIAGNOSTICS, INC.
B1029-70A
In Commercial Distribution

  • 05391516747936 ()
B1029-70A

  • Clostridium difficile toxin A/B antigen IVD, control

Trinity Biotech - 05391516748780

Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206631
In Commercial Distribution

  • 05391516748780 ()
1206631

  • Clostridium difficile toxin A/B antigen IVD, control

Emit Cyclosporine Sample - 00869164000079

No Description
FUJIREBIO DIAGNOSTICS, INC.
4008086
In Commercial Distribution

  • 00869164000079 ()

  • 100 tests per kit


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

Anti-Fya - 00858400005077

Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510215
In Commercial Distribution

  • 00858400005077 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody

Anti-Kpa - 00858400005022

Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510204
In Commercial Distribution

  • 00858400005022 ()


  • Anti-Kp^a red blood cell grouping IVD, antibody

RaPET® ASO - 00657498001233

Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
STANBIO LABORATORY, L.P.
1125-100
In Commercial Distribution

  • 00657498001233 ()
1125-100

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination

RaPET® ASO - 00657498001226

Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
STANBIO LABORATORY, L.P.
1125-050
In Commercial Distribution

  • 00657498001226 ()
1125-050

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination
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