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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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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)

INVADER - 15420045506701

No Description
Hologic, Inc.
INVADER FACTOR V, 1680 TESTS
Not in Commercial Distribution

  • 15420045506701 ()
95-457

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

INVADER - 15420045506664

No Description
Hologic, Inc.
INVADER FACTOR V, 144 TESTS
Not in Commercial Distribution

  • 15420045506664 ()
95-453

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

Unimed - 06945664817660

SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable
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