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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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

  • 00812117010359 ()
LM72OR

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

  • 00812117010342 ()
LM96

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

  • 00812117010311 ()
MDR272

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

  • 00812117010304 ()
MDR172

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

  • 00812117010144 ()
TS144A

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

  • 00812117010137 ()
TM144B

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

  • 00812117010120 ()
TM144A

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

  • 00812117018812 ()
LMBL72

  • 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

  • 00812117018805 ()
54030D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
For use in the microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
824101
Not in Commercial Distribution

  • 07611969953172 ()
824101

  • HLA class I & II antigen tissue typing IVD, control
for 18 detections of human HLA-B27 antigen in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823110
Not in Commercial Distribution

  • 07611969952908 ()
823110

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 3 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823070
Not in Commercial Distribution

  • 07611969952854 ()
823070

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823045
Not in Commercial Distribution

  • 07611969952830 ()
823045

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 3 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823031
Not in Commercial Distribution

  • 07611969952786 ()
823031

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823030
Not in Commercial Distribution

  • 07611969952779 ()
823030

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 6 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823023
Not in Commercial Distribution

  • 07611969952731 ()
823023

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 6 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823020
Not in Commercial Distribution

  • 07611969952717 ()
823020

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
Control-HLA-DR (pos.) (lyo.) 0,5 ml For use in the microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
824110
Not in Commercial Distribution

  • 07611969953196 ()
824110

  • HLA class I & II antigen tissue typing IVD, control
Control-HLA (neg.) (lyo.) 0,5 ml For use in the microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
824106
Not in Commercial Distribution

  • 07611969953189 ()
824106

  • HLA class I & II antigen tissue typing 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
No Description
CareDx AB
101.701-24u
In Commercial Distribution

  • 07340035507024 ()


  • 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
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

  • 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

  • 00814695023462 ()
LTPSAPBUF-B

  • 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

  • 00814695022892 ()
5341025D

  • 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

  • 00814695022823 ()
22000D

  • 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

  • 00814695022809 ()
SSPT1-G4

  • 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

  • 00814695022762 ()
RSOX1BT

  • 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

  • 00814695022748 ()
RSOW2B1T

  • 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

  • 00814695022724 ()
RSOW1BT

  • 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

  • 00814695022700 ()
RSSOX2B1

  • 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

  • 00814695022687 ()
RSSOX1B

  • 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
Dual syringe pumps and reagent reservoirs allow for higher throughput and planned maintenance routines. With its ability to process 500 bead regions simultaneously, there is significant increase in the size of screenable analytes.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022588 ()
LABSCNXS4

  • 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

  • 00814695022519 ()
A11256

  • 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

  • 00814695022489 ()
54390D

  • 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

  • 00814695022465 ()
54370D

  • 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

  • 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

  • 00814695022304 ()
542160D

  • 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

  • 00814695022281 ()
542140D

  • 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

  • 00814695022229 ()
54190D

  • 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
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