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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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Exact Diagnostics - 00812242030048

CMV Low Run Control
EXACT DIAGNOSTICS, LLC
CMVL101
In Commercial Distribution

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Exact Diagnostics - 00812242030031

CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030024

HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030017

HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030000

HIV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HIVP100
In Commercial Distribution

  • 00812242030000 ()
HIVP100

  • HIV1 nucleic acid IVD, calibrator

LABType™ HD Class I DRB1 Typing Test - 1000 tests - 00812117017945

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

  • 00812117017945 ()
RSSOH2B1X

  • 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™ HD Class I B Locus Typing Test - 1000 tests - 00812117017921

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

  • 00812117017921 ()
RSSOH1BX

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

LABType™ HD Class I A Locus Typing Test - 1000 tests - 00812117017914

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

  • 00812117017914 ()
RSSOH1AX

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

LABType™ SSO Class II DQA1/DQB1 Typing Test - 1000 tests - 00812117017907

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

  • 00812117017907 ()
RSSO2QX

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

LABType™ SSO Class II DRB1 Typing Test - 1000 tests - 00812117017891

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

  • 00812117017891 ()
RSSO2B1X

  • 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

LABType™ SSO Class I A Locus Typing Test - 1000 tests - 00812117017877

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

  • 00812117017877 ()
RSSO1AX

  • 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

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*16/17/18 - 00812117016962

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

  • 00812117016962 ()
SSPR1-C16

  • 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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - C*12 - 00812117016931

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

  • 00812117016931 ()
SSPR1-C12

  • 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

HNA Genotyping Tray - 00812117016511

For the molecular determination of neutrophil polymorphisms.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117016511 ()


  • 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 -DRB40103N - 00812117016474

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

  • 00812117016474 ()
SSPT2-G2

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

Micro SSP™ AmbiStrips™ HLA Class II -DRB50108N - 00812117016467

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

  • 00812117016467 ()
SSPT1-F2

  • 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 Combo - 00812117016443

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

  • 00812117016443 ()
SSPT1MX01

  • 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 - B27+ B73 - 00812117016429

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

  • 00812117016429 ()
SSPT1-G1

  • 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 - A0101N - 00812117016405

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

  • 00812117016405 ()
SSPT1-E1

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