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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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AllSet+™ Gold SSP B*15 High Resolution Kit - 00814695022120

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 B*14 High Resolution Kit - 00814695022113

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

  • 00814695022113 ()
541200D

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

AllSet+™ Gold SSP B*18 High Resolution Kit - 00814695022106

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 B*22 High Resolution Kit - 00814695022083

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 B*27 High Resolution Kit - 00814695022076

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

  • 00814695022076 ()
541160D

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

AllSet+™ Gold SSP B*38/39 High Resolution Kit - 00814695022069

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 A*01/36 High Resolution Kit - 00814695022052

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

  • 00814695022052 ()
541140D

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

AllSet+™ Gold SSP A*03 High Resolution Kit - 00814695022045

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

  • 00814695022045 ()
541130D

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

AllSet+™ Gold SSP B*17 High Resolution Kit - 00814695022038

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 A*10 High Resolution Kit - 00814695022021

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

  • 00814695022021 ()
541110D

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

AllSet+™ Gold SSP A*02 High Resolution Kit - 00814695022014

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 A*11 High Resolution Kit - 00814695022007

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

  • 00814695022007 ()
541100D

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

AllSet+™ Gold SSP DPA1 Locus High Resolution Kit - 00814695021994

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 DRB345 Locus High Resolution Kit - 00814695021987

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

  • 00814695021987 ()
54080D

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

AllSet+™ Gold SSP DPB1 Locus High Resolution Kit - 00814695021970

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 DQA1 Locus High Resolution Kit - 00814695021963

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 DQB1 Locus High Resolution Kit - 00814695021956

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

  • 00814695021956 ()
54050D

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

AllSet+™ Gold SSP DRB1 Locus High Resolution Kit - 00814695021949

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

Micro SSP™ AmbiStrips™ HLA Class II -DRB40103N - 00814695021932

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

  • 00814695021932 ()
SSPT1-G2

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

uTYPE™ Dx HLA Sequence Analysis Software - 00814695021765

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™ DPB1 Locus Sequencing Kit - 00814695021741

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™ DRB1, DRB3, DRB4, DRB5 Locus Sequencing Kit Group Specific Set - 00814695021734

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

  • 00814695021734 ()
5331025

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

SeCore™ DRB1 Locus Sequencing Kit - 00814695021727

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™ C Locus Sequencing Kit - 00814695021710

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

  • 00814695021710 ()
5320025

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

SeCore™ B Locus Sequencing Kit - Group Specific Set - 00814695021703

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

SeCore™ A Locus Sequencing Kit - 00814695021697

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

  • 00814695021697 ()
5300025

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

Phosphate Buffered Saline/Citrate Reagent - 00814695020492

FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695020492 ()
PC1-500

  • Cell centrifugation/density gradient separation reagent IVD

LABType™ SAPE Buffer - 00814695020461

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

  • 00814695020461 ()
LTSPSAPBU

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

LABType™ SAPE Buffer - 00814695020454

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

Micro SSP™ Gel System - 108 Wells - 00814695024452

The Micro SSP Gel Box System is a compact gel box for electrophoresis.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695024452 ()
MGS108

  • Electrophoresis chamber IVD
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