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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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Terasaki HLA-ABC First Tissue Typing Tray - 00812117010014

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010014 ()
T1-72

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

LABType™ HD Class I C Locus Typing Test - 1000 tests - 00812117017938

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017938 ()
RSSOH1CX

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

LABType™ SSO Class I B Locus Typing Test - 1000 tests - 00812117017884

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017884 ()
RSSO1BX

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

AllSet+™ Gold SSP A Locus High Resolution Kit - 00812117017822

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

  • 00812117017822 ()
54010D

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

SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017563

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

  • 00812117017563 ()
A15573

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

Micro SSP™ Japanese HLA Class I and II A,B,C,DRB,DQB1 DNA Typing Tray - 00812117017198

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017198 ()
SSPJPN

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

Terasaki HLA-ABC Oriental Special Tissue Typing Tray - 00812117017006

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
n/a
In Commercial Distribution

  • 00812117017006 ()
TM72OR

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*03 - 00812117016979

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016979 ()
SSPR2-103

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*15 - 00812117016955

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016955 ()
SSPR1-C15

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*14 - 00812117016948

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016948 ()
SSPR1-C14

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

HLA-ABC Typing Tray Set - 00812117016924

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
n/a
In Commercial Distribution

  • 00812117016924 ()
2TS144

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

Terasaki HLA-B27 Dry Tissue Typing Tray - 6-test tray - 00812117016900

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
n/a
In Commercial Distribution

  • 00812117016900 ()
27-06D

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

uTYPE™ CDx HLA Sequence Analysis Software - 00812117016849

The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system
ONE LAMBDA, INC.
UTPCDX-PGR
In Commercial Distribution

  • 00812117016849 ()
UTPCDX-PGR

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

SeCore™ CDx HLA GSSP Kit - 00812117016825

The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-GSSP
In Commercial Distribution

  • 00812117016825 ()
SECCDX-GSSP

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

Micro SSP™ Generic HLA Class II DRB, DQB, DPB DNA Typing Tray - 00812117016610

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016610 ()
SSPDRQP1

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

Micro SSP™ AmbiStrips™ Negative Control - 00812117016481

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016481 ()
SSPT1-H1

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

Micro SSP™ AmbiStrips™ HLA Class II -DRB50110N - 00812117016450

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016450 ()
SSPT1-E2

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

Micro SSP™ AmbiStrips™ HLA Class I - B27+ B81 - 00812117016436

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016436 ()
SSPT1-F1

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

Micro SSP™ AmbiStrips™ HLA Class I - C0409N - 00812117016412

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016412 ()
SSPT1-H2

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

Micro SSP™ AmbiStrips™ HLA Class I - AmB55 - 00812117016313

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016313 ()
SSPT1-D3

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

Micro SSP™ AmbiStrips™ HLA Class I - AmB5619N - 00812117016290

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016290 ()
SSPT1-C3

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

Micro SSP™ AmbiStrips™ HLA Class I - AmB4803 - 00812117016283

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016283 ()
SSPT1-C2

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

Micro SSP™ AmbiStrips™ HLA Class I - AmB5623 - 00812117016252

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016252 ()
SSPT1-A2

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB5 - 00812117016177

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016177 ()
SSPR2-5

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*08 - 00812117016146

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016146 ()
SSPR2-108

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*04 - 00812117016122

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016122 ()
SSPR2-104

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB3 - 00812117016115

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016115 ()
SSPR2-3

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*47 - 00812117016092

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016092 ()
SSPR1-47

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*41 - 00812117016078

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016078 ()
SSPR1-41

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*26 - 00812117016061

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016061 ()
SSPR1-26

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*24 - 00812117016047

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016047 ()
SSPR1-24

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*54-56 - 00812117016030

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016030 ()
SSPR1-22

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*14 - 00812117016016

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016016 ()
SSPR1-14

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*02 - 00812117015996

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015996 ()
SSPR1-A2

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB3 - 00812117015972

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015972 ()
SSPR2-3

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*38/39 - 00812117015965

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015965 ()
SSPR1-16

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*18 - 00812117015958

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015958 ()
SSPR1-18

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*03 - 00812117015934

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015934 ()
SSPR1-03

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

LABType™ SSO Class II DPA1/DPB1 Typing Test - 00812117015835

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015835 ()
RSSO2P

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

Micro SSP™ Allele Specific HLA Class II DNA Typing Tray - DRB1*12 - 00812117015798

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015798 ()
SSPR2-112

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*53 - 00812117015774

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015774 ()
SSPR1-53

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*51/52/78 - 00812117015767

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015767 ()
SSPR1-05

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*46/67/81/82 - 00812117015750

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015750 ()
SSPR1-46

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*40 - 00812117015743

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015743 ()
SSPR1-40

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*37 - 00812117015736

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015736 ()
SSPR1-37

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*35 - 00812117015729

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015729 ()
SSPR1-35

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*07 - 00812117015712

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015712 ()
SSPR1-07

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*23 - 00812117015705

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015705 ()
SSPR1-23

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

Mouse IgG2b Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - 00812117015569

These purified monoclonal antibodies are intended for in vitro diagnostic or research use in a qualitative, whole blood procedure for direct immunofluorescence staining of HLA-B27 or other lymphocyte surface antigens with analysis by flow cytometry.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015569 ()
G2BF50X

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

Simultag™ HLA-B27 Fluorescein Isothiocyanate / CD3 R-Phycoerythrin Monoclonal An - 00812117015545

These purified monoclonal antibodies are intended for in vitro diagnostic or research use in a qualitative, whole blood procedure for direct immunofluorescence staining of HLA-B27 or other lymphocyte surface antigens with analysis by flow cytometry.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015545 ()
27FC3P50

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