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Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
FDA product code NPR · Class 2 · Hematology
17
Registered devices
4
Adverse events
2
Recalls
5
510(k) clearances
Devices with this code
INFINITI® Factor II-V Leiden Intellipac® Reagent Module — AUTOGENOMICS, INCINVADER — Hologic, Inc.Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONFactor II Prothrombin G20210A Kit — Roche Diagnostics GmbHINFINITI® Factor II-V Leiden Amplification Mix — AUTOGENOMICS, INCINFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine — AUTOGENOMICS, INCXpert HemosIL FII & FV — CEPHEIDINFINITI® Factor II Amplification Mix — AUTOGENOMICS, INCINVADER — Hologic, Inc.INFINITI® Factor II Intellipac® Reagent Module — AUTOGENOMICS, INCINFINITI® Factor II BioFilmChip® Microarray Magazine — AUTOGENOMICS, INCHypercoagulation Panel (HC) Sample Buffer — LUMINEX CORPORATIONHypercoagulation Panel (HC) Nucleic Acid Test Cartridge — NANOSPHERE, INC.GeneXpert® — CEPHEIDHypercoagulation Panel (HC) Sample Buffer — NANOSPHERE, INC.Xpert Factor II & Factor V — CEPHEIDcobas Factor II and Factor V Test — Roche Molecular Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-10-26 | Roche Diagnostics Operations, Inc. | If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the dat |
| 2009-03-12 | Roche Molecular Systems, Inc. | Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and |
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