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 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

  • 00814695022113 ()
541200D

  • 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

  • 00814695022076 ()
541160D

  • 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

  • 00814695022052 ()
541140D

  • 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

  • 00814695022045 ()
541130D

  • 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

  • 00814695022021 ()
541110D

  • 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

  • 00814695022007 ()
541100D

  • 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

  • 00814695021987 ()
54080D

  • 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

  • 00814695021956 ()
54050D

  • 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
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
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

  • 00814695021734 ()
5331025

  • 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

  • 00814695021710 ()
5320025

  • 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
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
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
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
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
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
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

  • 00814695024391 ()
RSSOW1CRS

  • 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

  • 00814695024384 ()
RSSOW2B1S

  • 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

  • 00814695024377 ()
RSSOW1CS

  • 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

  • 00814695024360 ()
RSSOW1BS

  • 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

  • 00814695024353 ()
RSSOW1AS

  • 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

  • 00814695024346 ()
RSSOX1CRS

  • 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

  • 00814695024339 ()
RSSOX2B1S

  • 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

  • 00814695024322 ()
RSSOX1CS

  • 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

  • 00814695024315 ()
RSSOX1BS

  • 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

  • 00814695024308 ()
RSSOX1AS

  • 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

  • 00814695024292 ()
RSSO2345S

  • 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

  • 00814695024285 ()
RSSO2B1S

  • 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

  • 00814695024278 ()
RSSO2QS

  • 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

  • 00814695024261 ()
RSSO2PS

  • 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

  • 00814695024254 ()
RSSO1CS

  • 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

  • 00814695024247 ()
RSSO1E47S

  • 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

  • 00814695024230 ()
RSSO1S1S

  • 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

  • 00814695024223 ()
RSSO1S4S

  • 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

  • 00814695024216 ()
RSSO1BS

  • 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

  • 00814695024209 ()
RSSO1AS

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