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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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Barkey plasmatherm C&G - 04059201001817

Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-C&G
In Commercial Distribution

  • 04059201001817 ()
00003475

  • Cryopreserved blood/tissue thawing unit

Barkey plasmatherm V - 04059201001701

Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-V
In Commercial Distribution

  • 04059201001701 ()
00003296

  • Cryopreserved blood/tissue thawing unit

plasmatherm - 04059201000018

Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-TCP
In Commercial Distribution

  • 04059201000018 ()
00000460

  • Cryopreserved blood/tissue thawing unit

plasmatherm - 04059201000001

Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US
In Commercial Distribution

  • 04059201000001 ()
00000448

  • Cryopreserved blood/tissue thawing unit

TANGO optimo - 07611969961696

Instrument
Bio-Rad Medical Diagnostics GmbH
848900010
In Commercial Distribution

  • 07611969961696 ()
848900010

  • Immunohaematology/blood bank analyser IVD

Lymphoscreen ABC-60 - 07611969952939

Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969952939 ()
823300

  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)

Coombscell-E - 07611969952502

IgG-coated red blood cells for the control of antiglobulin test; 10ml
Bio-Rad Medical Diagnostics GmbH
816030100
In Commercial Distribution

  • 07611969952502 ()
816030100

  • Immunoglobulin-sensitized reagent red blood cell IVD, control

IH-Internal QC - 07611969952342

For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)
Bio-Rad Medical Diagnostics GmbH
814172100
In Commercial Distribution

  • 07611969952342 ()


  • Multiple immunohaematology test IVD, control

IH-Basic QC - 07611969952335

Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System
Bio-Rad Medical Diagnostics GmbH
814171100
In Commercial Distribution

  • 07611969952335 ()


  • Multiple immunohaematology test IVD, control

IH-Card Neutral - 07611969952229

Gel card for use with the IH system; Card for antibody detection of human red blood cells; 48 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813611100
In Commercial Distribution

  • 07611969952229 ()
813611100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
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