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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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Dr.PRP - 08809410200008

The Dr.PRP is provided as individually packaged sterile, single-use, disposable concentrating unit which is composed of medical grade polymer and elastomer. The concentrating unit has 20 ml of volume capacity and is designed to work with a swing rotor type general-purpose centrifuge.
Rmedica Co.,Ltd
Dr.PRP
In Commercial Distribution

  • 08809410200008 ()
RMLFT-001(EN)

  • Apheresis system

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 - 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

Negative Serum Control - 10888234500520

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404574
Not in Commercial Distribution

  • 10888234500520 ()
404574

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Eluting Solution - 10888234500490

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404565
Not in Commercial Distribution

  • 10888234500490 ()
404565

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Buffering Solution - 10888234500476

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404560
Not in Commercial Distribution

  • 10888234500476 ()
404560

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Specimen Diluent - 10888234500445

For Use with LIFECODES B-Screen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403831
Not in Commercial Distribution

  • 10888234500445 ()
403831

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Concentrated Wash (10X) - 10888234500407

For Use with Factor VIII Antibody Screen and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403622
In Commercial Distribution

  • 10888234500407 ()
403622

  • HLA class I antibody screening IVD, reagent

Substrate Buffer - 10888234500377

For Use with Factor VIII Antibody Screen, PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LIFECODES QuikScreen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403613
Not in Commercial Distribution

  • 10888234500377 ()
403613

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Stopping Solution - 10888234500360

For Use with PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LIFECODES QuikScreen, DonorScreen-HLA Class I and Class II, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403603
Not in Commercial Distribution

  • 10888234500360 ()
403603

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
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