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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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Skin Stapler
Covidien LP
054006
In Commercial Distribution

  • 20884521080666 ()
  • 10884521080669 ()

  • Width,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
No Description
FUJIREBIO DIAGNOSTICS, INC.
4008086
In Commercial Distribution

  • 00869164000079 ()

  • 100 tests per kit


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
No Description
Roche Molecular Systems, Inc.
07402678190
In Commercial Distribution

  • 00875197005646 ()
07402678190

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
07402660190
In Commercial Distribution

  • 00875197005639 ()
07402660190

  • Influenza A/B virus nucleic acid IVD, control
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z164U
In Commercial Distribution

  • 05060242472497 ()
  • 05060242472480 ()
  • 05060242472503 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z162U
In Commercial Distribution

  • 05060242471704 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
This Anti-Fya reagent is for the in vitro detection and identification of the human Fya blood group antigen by Indirect Antiglobulin Test.
ALBA BIOSCIENCE LIMITED
Z152U
In Commercial Distribution

  • 05060242471698 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Wra (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z231U
In Commercial Distribution

  • 05060242471056 ()


  • Anti-Wr^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-Lea (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z212U
In Commercial Distribution

  • 05060242471025 ()


  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAsera Anti-Fya (Polyclonal) for indirect antiglobulin test by tube technique.
ALBA BIOSCIENCE LIMITED
Z151U
Not in Commercial Distribution

  • 05060242470974 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
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
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
Cyclosporine - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10335454
In Commercial Distribution

  • 00630414524481 ()
4567682

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
CSA Pretreatment - CENTAUR - CONS - 2x26mL
Siemens Healthcare Diagnostics Inc.
10335453
In Commercial Distribution

  • 00630414524474 ()
  • 00630414003689 ()
4567127

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
CSA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10334651
In Commercial Distribution

  • 00630414523798 ()
3685177

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Siemens Healthcare Diagnostics Inc.
10995552
In Commercial Distribution

  • 00630414598765 ()
  • 00630414007465 ()
10995552

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995551
In Commercial Distribution

  • 00630414598758 ()
10995551

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Cyclosporine (CsA) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995549
In Commercial Distribution

  • 00630414598734 ()
  • 00842768027383 ()
10995549

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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
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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