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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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Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*58 - 00812117014784

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

  • 00812117014784 ()
SSPR1-58

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*57 - 00812117014777

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

  • 00812117014777 ()
SSPR1-57

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*48 - 00812117014760

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

  • 00812117014760 ()
SSPR1-48

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*42 - 00812117014753

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

  • 00812117014753 ()
SSPR1-42

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*33 - 00812117014746

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

  • 00812117014746 ()
SSPR1-33

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*32 - 00812117014739

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

  • 00812117014739 ()
SSPR1-32

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*31 - 00812117014722

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

  • 00812117014722 ()
SSPR1-31

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*30 - 00812117014715

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

  • 00812117014715 ()
SSPR1-30

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*29 - 00812117014708

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

  • 00812117014708 ()
SSPR1-29

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*27 - 00812117014692

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

  • 00812117014692 ()
SSPR1-27

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*15 - 00812117014685

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

  • 00812117014685 ()
SSPR1-15

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*08 - 00812117014678

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

  • 00812117014678 ()
SSPR1-08

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

Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - A*01/36 - 00812117014661

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

  • 00812117014661 ()
SSPR1-01

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

Micro SSP™ Null Allele Specific HLA Class II DNA Typing Tray - 00812117014647

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

  • 00812117014647 ()
SSP2-NL

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

Micro SSP™ Null Allele Specific HLA Class I DNA Typing Tray - 00812117014630

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

  • 00812117014630 ()
SSP1-NL

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

LABType™ HD Class I B Locus Typing Test - 00812117014579

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

  • 00812117014579 ()
RSSOH1B

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

LABType™ HD Class I A Locus Typing Test - 00812117014562

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

  • 00812117014562 ()
RSSOH1A

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

LABType™ HD Class II DRB1 Typing Test - 00812117014555

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

  • 00812117014555 ()
RSSOH2B1

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

Micro SSP™ High Resolution HLA Class II DNA Typing Tray - 00812117011783

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

  • 00812117011783 ()
SSP2H

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

Micro SSP™ HLA Class I DNA Typing Tray - AB - 00812117011776

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

  • 00812117011776 ()
SSP1AB

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

Micro SSP™ Generic HLA Class I and II ABDR DNA Typing Tray - 00812117011752

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

  • 00812117011752 ()
SSPABDR

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

Micro SSP™ Generic HLA Class II DNA Typing Tray - DQB1 Only - 00812117011745

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

  • 00812117011745 ()
SSP2LQB1

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

Micro SSP™ Generic HLA Class II DNA Typing Tray - 00812117011738

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

  • 00812117011738 ()
SSP2L

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

Micro SSP™ Generic HLA Class I and II DNA Typing Tray - ABDRDQ - 00812117011721

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

  • 00812117011721 ()
SSPML02

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

Micro SSP™ Generic HLA Class II DNA Typing Tray - DRB Only - 00812117011714

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

  • 00812117011714 ()
SSP2LB

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

Micro SSP™ HLA Class I C Locus Specific DNA Typing Tray - 00812117011691

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

  • 00812117011691 ()
SSP1C

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

Micro SSP™ HLA Class I B Locus Specific DNA Typing Tray - 00812117011684

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

  • 00812117011684 ()
SSP1B

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

Micro SSP™ HLA Class I A Locus Specific DNA Typing Tray - 00812117011677

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

  • 00812117011677 ()
SSP1A

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

Micro SSP™ Generic HLA Class I DNA Typing Tray - 00812117011660

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

  • 00812117011660 ()
SSP1L

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

LABType™ SSO MICA - 00812117011219

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

  • 00812117011219 ()
RSSOMICA

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

LABType™ SSO Class II DQA1/DQB1 Typing Test - 00812117011141

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

  • 00812117011141 ()
RSSO2Q

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

LABType™ SSO Class I B7 Supplement Typing Test - 00812117011134

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

  • 00812117011134 ()
RSSO1S1

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

LABType™ SSO Class I Bw4 Supplement Typing Test - 00812117011127

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

  • 00812117011127 ()
RSSO1S4

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

LABType™ SSO Class II DRB3,4,5 Typing Test - 00812117011097

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

  • 00812117011097 ()
RSSO2345

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

LABType™ SSO Class II DRB1 Typing Test - 00812117011080

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

  • 00812117011080 ()
RSSO2B1

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

LABType™ SSO Class I C Locus Typing Test - 00812117011066

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

  • 00812117011066 ()
RSSO1C

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

LABType™ SSO Class I B Locus Typing Test - 00812117011059

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

  • 00812117011059 ()
RSSO1B

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

LABType™ SSO Class I A Locus Typing Test - 00812117011042

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

  • 00812117011042 ()
RSSO1A

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

Exact Diagnostics - 00812242031144

HAI Negative Run Control
EXACT DIAGNOSTICS, LLC
NEGHAI
In Commercial Distribution

  • 00812242031144 ()
NEGHAI

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242031137

Synthetic Negative Run Control
EXACT DIAGNOSTICS, LLC
NEGSYN
In Commercial Distribution

  • 00812242031137 ()
NEGSYN

  • PCR/NAT negative control IVD
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