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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 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
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
1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. QUANTA Flash ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.
INOVA DIAGNOSTICS, INC.
701187
In Commercial Distribution

  • 08426950601944 ()


  • Beta-2-glycoprotein I antibody IVD, control
1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgA High Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative.
INOVA DIAGNOSTICS, INC.
701242
In Commercial Distribution

  • 08426950597353 ()


  • Beta-2-glycoprotein I antibody IVD, control
1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.
INSTRUMENTATION LABORATORY COMPANY
00009800022
In Commercial Distribution

  • 08426951301706 ()
  • 18426951301703 ()
00009800022

  • Beta-2-glycoprotein I antibody IVD, control
1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgG High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albumin, stabilizers and preservative.
INOVA DIAGNOSTICS, INC.
701247
In Commercial Distribution

  • 08426950595250 ()


  • Beta-2-glycoprotein I antibody IVD, control
1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative.
INOVA DIAGNOSTICS, INC.
701252
In Commercial Distribution

  • 08426950595038 ()


  • Beta-2-glycoprotein I antibody IVD, control
No Description
CareDx AB
101.708-24u
In Commercial Distribution

  • 07340035507147 ()


  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.701-06u
In Commercial Distribution

  • 07340035507048 ()


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