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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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eSensor® XT-8 - 00857167005191

eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005191 ()
KT021053

  • Multiple thrombophilia marker IVD, kit, clotting

INFINITI® Factor II-V Leiden Amplification Mix - 00850009370129

Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-3050-01
Not in Commercial Distribution

  • 00850009370129 ()
01-3050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

INFINITI® Factor II-V Leiden Intellipac® Reagent Module - 00850009370112

Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-2050-01
Not in Commercial Distribution

  • 00850009370112 ()
01-2050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine - 00850009370105

Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-1050-01
Not in Commercial Distribution

  • 00850009370105 ()
01-1050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

INFINITI® Factor V Leiden Amplification Mix - 00850009370099

Genotyping systme for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-3030-01
Not in Commercial Distribution

  • 00850009370099 ()
01-3030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

INFINITI® Factor V Leiden Intellipac® Reagent Module - 00850009370082

Genotyping system for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-2030-01
Not in Commercial Distribution

  • 00850009370082 ()
01-2030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine - 00850009370075

Genotyping system for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-1030-01
Not in Commercial Distribution

  • 00850009370075 ()
01-1030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Factor V Leiden Kit - 04038377021607

No Description
Roche Diagnostics GmbH
1
In Commercial Distribution

  • 04038377021607 ()
04618777001

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Xpert HemosIL FII & FV - 07332940000936

Xpert HemosIL FII & FV kit; 10 test kit
CEPHEID
GXHEMOSIL-10
In Commercial Distribution

  • 07332940000936 ()
GXHEMOSIL-10

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Xpert Factor II & Factor V - 07332940000240

Xpert Factor II & Factor V kit; 10 test kit
CEPHEID
GXFIIFV-10
In Commercial Distribution

  • 07332940000240 ()
GXFIIFV-10

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
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