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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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LABType™ SAPE Buffer - 00814695024063

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

  • 00814695024063 ()
LTSPSAPBU-B

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

LABType™ SAPE Buffer - 00814695023462

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

LABType™ SAPE Buffer - 00814695023455

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

  • 00814695023455 ()
LTPSAPBU1-B

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

Micro SSP™ AmbiStrips™ HLA Class I - A6811N - 00814695022816

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

  • 00814695022816 ()
SSPT1-H4

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

Micro SSP™ AmbiStrips™ HLA Class I - B1501N - 00814695022809

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

Micro SSP™ AmbiStrips™ HLA Class I - A0104N+A0321N+A2411N - 00814695022793

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

  • 00814695022793 ()
SSPT1-A3

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

LABType™ XR Class II DRB1 Locus Typing - 00814695022786

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

  • 00814695022786 ()
RSOX2B1T

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

LABType™ XR Class I C Locus Typing Test - 00814695022779

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

  • 00814695022779 ()
RSOX1CT

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

LABType™ XR Class I B Locus Typing Test - 00814695022762

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

LABType™ XR Class I A Locus Typing Test - 00814695022755

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

  • 00814695022755 ()
RSOX1AT

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

LABType™ CWD Class II DRB1 Locus Typing - 00814695022748

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

LABType™ CWD Class I C Locus Typing Test - 00814695022731

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

  • 00814695022731 ()
RSOW1CT

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

LABType™ CWD Class I B Locus Typing Test - 00814695022724

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

LABType™ CWD Class I A Locus Typing Test - 00814695022717

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

  • 00814695022717 ()
RSOW1AT

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

LABType™ XR Class II DRB1 Locus Typing Test - 00814695022700

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

LABType™ XR Class I C Locus Typing Test - 00814695022694

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

  • 00814695022694 ()
RSSOX1C

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

LABType™ XR Class I B Locus Typing Test - 00814695022687

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

LABType™ XR Class I A Locus Typing Test - 00814695022670

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

  • 00814695022670 ()
RSSOX1A

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

LABType™ CWD Class I DRB1 Locus Typing - 00814695022663

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

  • 00814695022663 ()
RSSOW2B1

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

LABType™ CWD Class I B Locus Typing Test - 00814695022649

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

  • 00814695022649 ()
RSSOW1B

  • 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

Exact Diagnostics - 00812242030918

SARS-CoV-2, Flu, RSV Negative Run Control
EXACT DIAGNOSTICS, LLC
COVFLUNEG
In Commercial Distribution

  • 00812242030918 ()
COVFLUNEG

  • Multiple-genus respiratory virus nucleic acid IVD, control

Exact Diagnostics - 00812242030901

SARS-CoV-2, Flu, RSV Positive Run Control
EXACT DIAGNOSTICS, LLC
COVFLU
In Commercial Distribution

  • 00812242030901 ()
COVFLU

  • Multiple-genus respiratory virus nucleic acid IVD, control

Exact Diagnostics - 00812242030895

SARS-CoV-2 Negative Run Control
EXACT DIAGNOSTICS, LLC
COV000CE
In Commercial Distribution

  • 00812242030895 ()
COV000CE

  • SARS-CoV-2 nucleic acid IVD, control

Exact Diagnostics - 00812242030888

SARS-CoV-2 Positive Run Control
EXACT DIAGNOSTICS, LLC
COV019CE
In Commercial Distribution

  • 00812242030888 ()
COV019CE

  • SARS-CoV-2 nucleic acid IVD, control

Exact Diagnostics - 00812242030857

RP Negative Run Control
EXACT DIAGNOSTICS, LLC
RPNEG
In Commercial Distribution

  • 00812242030857 ()
RPNEG

  • Multiple-genus respiratory virus nucleic acid IVD, control

Exact Diagnostics - 00812242030840

RP Positive Run Control
EXACT DIAGNOSTICS, LLC
RPPOS
In Commercial Distribution

  • 00812242030840 ()
RPPOS

  • Multiple-genus respiratory virus nucleic acid IVD, control

Exact Diagnostics - 00812242030802

Ehrlichia Run Control
EXACT DIAGNOSTICS, LLC
ERLRC
In Commercial Distribution

  • 00812242030802 ()
ERLRC

  • Ehrlichia chaffeensis nucleic acid IVD, control

Exact Diagnostics - 00812242030796

Borrelia Run Control
EXACT DIAGNOSTICS, LLC
BORRC
In Commercial Distribution

  • 00812242030796 ()
BORRC

  • Borrelia burgdorferi nucleic acid IVD, control

Exact Diagnostics - 00812242030789

Bartonella Run Control
EXACT DIAGNOSTICS, LLC
BRTRC
In Commercial Distribution

  • 00812242030789 ()
BRTRC

  • Bartonella quintana nucleic acid IVD, control

Exact Diagnostics - 00812242030772

Babesia Run Control
EXACT DIAGNOSTICS, LLC
BABRC
In Commercial Distribution

  • 00812242030772 ()
BABRC

  • Babesia microti nucleic acid IVD, control

Exact Diagnostics - 00812242030765

Anaplasma Run Control
EXACT DIAGNOSTICS, LLC
ANARC
In Commercial Distribution

  • 00812242030765 ()
ANARC

  • Anaplasma phagocytophilum nucleic acid IVD, control

Exact Diagnostics - 00812242030758

Respiratory Run Control
EXACT DIAGNOSTICS, LLC
RPRC
Not in Commercial Distribution

  • 00812242030758 ()
RPRC

  • Multiple-genus respiratory virus nucleic acid IVD, control

Exact Diagnostics - 00812242030741

CT/NG Verification Panel
EXACT DIAGNOSTICS, LLC
CTNGP200
In Commercial Distribution

  • 00812242030741 ()
CTNGP200

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Exact Diagnostics - 00812242030734

C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control

Exact Diagnostics - 00812242030727

MRSA Verification Panel
EXACT DIAGNOSTICS, LLC
MRSAP200
In Commercial Distribution

  • 00812242030727 ()
MRSAP200

  • MRSA/MSSA nucleic acid IVD, control

Exact Diagnostics - 00812242030710

HSV Verification Panel
EXACT DIAGNOSTICS, LLC
HSVP200
In Commercial Distribution

  • 00812242030710 ()
HSVP200

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Exact Diagnostics - 00812242030697

HBV 1E6 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVH202
In Commercial Distribution

  • 00812242030697 ()
HBVH202

  • Hepatitis B virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030680

HBV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVL201
In Commercial Distribution

  • 00812242030680 ()
HBVL201

  • Hepatitis B virus nucleic acid IVD, calibrator
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