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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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Haemonetics - 10887691305303

LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10BLA
In Commercial Distribution

  • 30887691305307 ()
  • 10887691305303 ()


  • Blood transfusion filter

Haemonetics Leukotrap SC RC - 10887691304214

Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter
HAEMONETICS CORPORATION
BPFBLA
In Commercial Distribution

  • 30887691304218 ()
  • 10887691304214 ()


  • Blood transfusion filter

Haemonetics - 10887691003872

Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC Aliquot Bag with Needleless Injection Port
HAEMONETICS CORPORATION
NEO1
In Commercial Distribution

  • 30887691003876 ()
  • 10887691003872 ()


  • Blood transfusion filter

Haemonetics - 10887691000758

BPF Leukocyte Reduction Filteration System
HAEMONETICS CORPORATION
BPFB
In Commercial Distribution

  • 30887691000752 ()
  • 10887691000758 ()


  • Blood transfusion filter

Haemonetics - 10887691000703

LRF High Efficiency Leukocyte Reduction Filtration System for Platelets
HAEMONETICS CORPORATION
LRFP
In Commercial Distribution

  • 30887691000707 ()
  • 10887691000703 ()


  • Blood transfusion filter

Haemonetics - 10887691000437

LRF 10 High Efficiency Leukocyte Reduction Filter for platelets with Attached 1.3L CLX Transfer Bag
HAEMONETICS CORPORATION
LRF10S
In Commercial Distribution

  • 30887691000431 ()
  • 10887691000437 ()


  • Blood transfusion filter

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

ThromboType® - 10888234500285

ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution

  • 10888234500285 ()
THROMBOTYPE

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

ThromboType®1 - 10888234500261

ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE1
In Commercial Distribution

  • 10888234500261 ()
THROMBOTYPE1

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

PakPlus® - 10888234500254

The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS
In Commercial Distribution

  • 10888234500254 ()
PAKPLUS

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)

PakAuto® - 10888234500247

PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKAUTO
Not in Commercial Distribution

  • 10888234500247 ()
PAKAUTO

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)

Pak2-LE - 10888234500230

Pak2-LE is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK2-LE
Not in Commercial Distribution

  • 10888234500230 ()
PAK2-LE

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)

LIFECODES® QuikScreen® - 10888234500094

LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)

LIFECODES® B-Screen® - 10888234500063

LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class II antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
BCSG
Not in Commercial Distribution

  • 10888234500063 ()
BCSG

  • HLA class II antibody screening IVD, kit, enzyme immunoassay (EIA)

Dilution Solution - 10888234400769

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515
In Commercial Distribution

  • 10888234400769 ()
628515

  • Buffered sample diluent IVD

Dilution Solution - 10888234400745

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628155
Not in Commercial Distribution

  • 10888234400745 ()
628155

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Negative Control Serum - 10888234400622

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403887
Not in Commercial Distribution

  • 10888234400622 ()
403887

  • HLA class II antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400615

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403892
Not in Commercial Distribution

  • 10888234400615 ()
403892

  • HLA class II antigen tissue typing IVD, kit, multiplex

Negative Control Serum - 10888234400592

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

  • HLA class I antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400585

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

  • HLA class I antigen tissue typing IVD, kit, multiplex

LIFECODES Wash Buffer - 10888234400578

For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628221
Not in Commercial Distribution

  • 10888234400578 ()
628221

  • HLA class I antigen tissue typing IVD, kit, multiplex
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