NPQ · Class II · 21 CFR 864.7280

FDA Product Code NPQ: Test, Factor V Leiden Mutations, Genomic Dna Pcr

In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.

Leading manufacturers include Roche Diagnostics Corp., AutoGenomics, Inc. and Cepheid.

6
Total
5
Cleared
252d
Avg days
2003
Since

FDA 510(k) Cleared Test, Factor V Leiden Mutations, Genomic Dna Pcr Devices (Product Code NPQ)

6 devices
1–6 of 6
Cleared Jun 01, 2011
INVADER FACTOR V
K100980
Hologic, Inc.
Pathology · 419d
Cleared Apr 28, 2010
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
K093129
Illumina, Inc.
Pathology · 208d
Cleared Apr 22, 2010
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
K093974
Osmetech Molecular Diagnostics
Pathology · 120d
Cleared Sep 18, 2009
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
K082118
Cepheid
Pathology · 417d
Cleared Feb 07, 2007
INFINITI SYSTEM
K060564
AutoGenomics, Inc.
Pathology · 341d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005
Roche Diagnostics Corp.
Pathology · 9d

About Product Code NPQ - Regulatory Context