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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HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022786 ()
RSOX2B1T

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022755 ()
RSOX1AT

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022694 ()
RSSOX1C

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022670 ()
RSSOX1A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022656 ()
RSSOW1C

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022632 ()
RSSOW1A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022496 ()
790111

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022472 ()
54380D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022441 ()
54350D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022427 ()
54330D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022403 ()
54310D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022380 ()
54290D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022366 ()
54270D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022342 ()
54250D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022328 ()
54230D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022311 ()
54220D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022298 ()
542150D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022274 ()
542130D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022267 ()
542120D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022243 ()
54210D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022236 ()
542100D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022212 ()
54180D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022199 ()
54160D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022175 ()
54140D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022151 ()
541230D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022137 ()
541210D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022120 ()
54120D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022106 ()
541190D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022083 ()
541170D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022069 ()
541150D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022038 ()
541120D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022014 ()
54110D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021994 ()
54090D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021970 ()
54070D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021963 ()
54060D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021949 ()
54040D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Processes DNA sample data files of Class I and Class II Human Leukocyte Antigens (HLA) for analysis and HLA allele assignment by comparison to the IMGT/HLA database with uTYPE. The sample data files are generated from samples processed with SeCore™ SBT Sequencing kits or GSSP SBT Sequencing kits and the Applied Biosystems Genetic Analyzer.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021765 ()
539993

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021741 ()
5351025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021727 ()
5330025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021703 ()
5310025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695020454 ()
LTSPSAPBR

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
CARTRIDGE, cTnI
ABBOTT POINT OF CARE INC.
06P23-25
Not in Commercial Distribution

  • 10054749001986 ()
  • 00054749001989 ()
06P23-25

  • Troponin I IVD, reagent
TROPONIN CARTRIDGE
ABBOTT POINT OF CARE INC.
03P90-25
In Commercial Distribution

  • 10054749000187 ()
  • 00054749000180 ()
03P90-25

  • Troponin I IVD, reagent
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)
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)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211049 ()


  • Troponin I IVD, reagent
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls
INSTRUMENTATION LABORATORY COMPANY
0009802116
In Commercial Distribution

  • 08426950497028 ()
0009802116

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, control
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls
INSTRUMENTATION LABORATORY COMPANY
0009802112
In Commercial Distribution

  • 08426950497011 ()
0009802112

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, control
EliA ß2-Glycoprotein I IgM Well
Phadia AB
DECC055330
In Commercial Distribution

  • 07333066010809 ()
  • 07333066014760 ()
DECC055330

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
EliA ß2-Glycoprotein I IgG Well
Phadia AB
DECC055320
In Commercial Distribution

  • 07333066010793 ()
  • 07333066014753 ()
DECC055320

  • Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay
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