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DONOR TESTING

ABO/Rh
Manufacturer:Olympus America Inc., Melville, NY
Test Name:Olympus PK7200 Automated Pretransfusion Blood Testing System
License:U.S. License No. 0435


Alternate Cytomegalovirus (CMV) Screen
Manufacturer:Immucor, Inc., Norcross, GA
Test Name:Capture-CMV
License:U.S. License No. 0886


Alternate Syphilis Serology: RPR
Manufacturer:ASI
Test Name:RPR Card Test
License:Not Applicable


Antibody Screen
Manufacturer:Medion Diagnostics, Düdingen, Sweden
Test Name:Search-Cyte Duo for TANGO 3-3.5%
License:U.S. License No. 1740


Anti-HBc ChLIA
Manufacturer:Abbott Laboratories
Test Name:Abbott PRISM® HBcore (Hepatitis B Virus Core Antigen, E. coli, Recombinant)
License:U.S. License No. 43
List Number:6E66


Anti-HBs EIA
Manufacturer:Abbott Laboratories
Test Name:Qualitative Determination of Antibody to Hepatitis B Surface Antigen
License:U.S. License No. 43


Anti-HCV ChLIA (Implementation 8/07)
Manufacturer:Abbott Laboratories
Test Name:Abbott PRISM® HCV (Hepatitis C Virus Encoded Antigens, Recombinant c100-3, HCr43, NS5)
License:U.S. License No. 43
List Number:6D18


Anti-HCV EIA
Manufacturer:Abbott Laboratories
Test Name:Hepatitis C Virus Encoded Antigen (Recombinant c100-3, HC-31, and HC-34) Abbott HCV EIA 2.0
License:U.S. License No. 43
List Number:4A14


Anti-HCV RIBA
Manufacturer:Chiron Corporation, Emeryville, CA
Test Name:Chiron RIBA HCV 3.0 Strip Immunoblot Assay (SIA)
License:U.S. License No. 1106


Anti-HIV-1 Western Blot
Manufacturer:Bio-Rad Laboratories Blood Virus Division Redmond, WA
Test Name:Human Immunodeficiency Virus Type 1 (HIV-1) Genetic SystemsTM Western Blot Kit
License:U.S. License No. 1109


Anti-HIV-1/HIV-2 EIA
Manufacturer:Abbott Laboratories
Test Name:Human Immunodeficiency Virus Types 1 and 2 (E. Coli, B. Megaterium Recombination Antigen) HIVABTM HIV-1/HIV-2 (rDNA) EIA
License:U.S. License No. 43
List Number:3A77


Anti-HIV-2 EIA
Manufacturer:Bio-Rad Laboratories Blood Virus Division Redmond, WA
Test Name:Human Immunodeficiency Virus Type 2, Genetic SystemsTM
License:U.S. License No. 1109


Anti-HTLV-I/HTLV-II EIA
Manufacturer:Abbott Laboratories
Test Name:Human T-Lymphotropic Virus Types I and Type II. Abbott HTLV-I/HTLV-II EIA
License:U.S. License No. 43
List Number:7A92


Cytomegalovirus (CMV) Screen
Manufacturer:Olympus America Inc., Melville, NY
Test Name:Olympus PK CMV-PA System
List Number:PA2300
Clearance:BK940092


HBsAg EIA
Manufacturer:Abbott Laboratories
Test Name:Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Peroxidase (Horseradish) Conjugate
License:U.S. License No. 43
List Number:1980


HBsAg ChLIA
Manufacturer:Abbott Laboratories
Test Name:Abbott PRISM® HBsAg (Antibody to Hepatitis B Surface Antigen, Mouse Monoclonal IgM)
License:U.S. License No. 43
List Number:6D19


HBsAg Confirmatory ChLIA
Manufacturer:Abbott Laboratories
Test Name:Abbott PRISM® Antibody to Hepatitis B Surface Antigen (Human)
License:U.S. License No. 43


HBsAg Neutralization EIA
Manufacturer:Abbott Laboratories
Test Name:Antibody to Hepatitis B Surface Antigen (Human)
License:U.S. License No. 43
List Number:1012


INNO-LIA HTLV I/II Score
Manufacturer:Innogenetics
Test Name:HTLV I/II
License:Not Applicable


Nucleic Acid Testing (NAT) HCV (Pooled testing for blood and plasma donors; individual testing for HCT/P donors as required by FDA)
Manufacturer:Roche Diagnostics
Test Name:COBAS AmpliScreenTM HCV Test, Version 2.0
License:U.S. License No. 1636


Nucleic Acid Testing (NAT) HIV-1 (Pooled testing for blood and plasma donors; individual testing for HCT/P donors as required by FDA)
Manufacturer:Roche Diagnostics
Test Name:COBAS AmpliScreenTM HIV-1 Test, Version 1.5
License:U.S. License No. 1636


Nucleic Acid Testing (NAT) West Nile Virus (WNV)
Manufacturer:Roche Diagnostics
Test Name:TaqScreen West Nile Virus Test
License:Under IND


Syphilis Serology
Manufacturer:Olympus America Inc., Melville, NY
Test Name:Olympus PK TP System
List Number:PH3000
Clearance:BK940053


Total Cholesterol
Manufacturer:Olympus America Inc., Melville, NY
Test Name:Cholesterol
License:Not Applicable




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