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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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Acuitas - 20812125010079

QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC043
Not in Commercial Distribution

  • 20812125010079 ()
AC043

  • Specimen processing instrument IVD

SUR-FIT NATURA - 00768455103379

SUR-FIT Natura® Drainable Pouch, 14" Tran W/1-Sided Comfort Panel, 4"
CONVATEC, PURCHASING DEPARTMENT
401515
In Commercial Distribution

  • 10768455103376 ()
  • 00768455103379 ()
  • 00768455182541 ()


  • Multiple-piece urostomy bag, open-ended

HarmonyAIR - 00724995172657

The HarmonyAIR M5 Dual Package with 2 Single Flat Panel Monitor, without Control, with 2 Flat Panel Monitors and Tandems, is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995172657 ()
LM03NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191580

The M5 High Density Dual Package, Single Flat Panel Monitor Mount, Auxiliary Arm Single Flat Panel Monitor, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191580 ()
LMH03

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

ALBAcyte Antibody Identification (16-Cell) - 05060242471384

Reagent Red Blood Cells, ALBAcyte Antibody Identification (16-Cell) for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z473U
In Commercial Distribution

  • 05060242471384 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

ALBAcyte Expanded Rh Negative Antibody Screen - 05060242471377

Reagent Red Blood Cells, ALBAcyte Expanded Rh Negative Antibody Screen for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z464U
In Commercial Distribution

  • 05060242471377 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

ALBAcyte 2-3% Reagent RBCs for Antibody Identification Panels (papain-treated) - 05060242471193

Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells (papain-treated) for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z472U
In Commercial Distribution

  • 05060242471193 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

ALBAcyte Reagent RBCs for Antibody Identification Panels (untreated) - 05060242471186

Reagent Red Blood Cells, ALBAcyte Antibody Identification Cells for tube techniques, 2-3% suspension.
ALBA BIOSCIENCE LIMITED
Z471U
In Commercial Distribution

  • 05060242471186 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Panoscreen EXTEND - 10888234002406

Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Panocell-20 - 10888234001843

This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as twenty (20) vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
IMMUCOR, INC.
0005020
In Commercial Distribution

  • 10888234001843 ()
0005020

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Panocell-10 - 10888234000396

This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 10 vials of reagent red blood cells in a set, as well as one (1) Tech Cell and also one (1) buffered preservation diluent. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
IMMUCOR, INC.
0003032
In Commercial Distribution

  • 10888234000396 ()
0003032

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Panocell-10, Ficin-Treated - 10888234000310

This product is used in the identification of unexpected red cell blood group antibodies. Panocell-10, Ficin-Treated is a 12-vial set of 10 vials of red blood cells, plus one vial each of Ficin Solution and Ficin Control.
IMMUCOR, INC.
0002385
In Commercial Distribution

  • 10888234000310 ()
0002385

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Panocell-16 - 10888234000242

This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 16 vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
IMMUCOR, INC.
0002332
In Commercial Distribution

  • 10888234000242 ()
0002332

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Data-Cyte Plus P 0.8% - 07640137342272

Reagent Red Blood Cells papainized panel used for identification of unexpected antibodies in gel technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
11x4ml
In Commercial Distribution

  • 07640137342272 ()
213688

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Data-Cyte Plus 3% - 07640137341749

Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
11x4 ml
In Commercial Distribution

  • 07640137341749 ()
213231

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Data-Cyte Plus 2 0.8% - 07640137341459

Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
11x4 ml
In Commercial Distribution

  • 07640137341459 ()
213641

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Data-Cyte Extend 0.8% - 07640137341442

Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. Data-Cyte Extend 0.8% cannot detect anti-D. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
4 x 4ml
In Commercial Distribution

  • 07640137341442 ()
213684

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Data-Cyte Plus 0.8% - 07640137340285

Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
Medion Grifols Diagnostics AG
11x4 ml
In Commercial Distribution

  • 07640137340285 ()
213654

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Data-Cyte Plus 3% - 07640137340278

Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
11x4 ml
Not in Commercial Distribution

  • 07640137340278 ()
213392

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Biotestcell®-I 11 Plus - 07611969952441

Reagent Red Blood Cells; 3.0 - 3.4%; for identification of unexpected antibodies with TANGO instruments and by tube test; 11x4ml
Bio-Rad Medical Diagnostics GmbH
816022100
In Commercial Distribution

  • 07611969952441 ()
816022100

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
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