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. and Hologic, Inc..

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
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005
Roche Diagnostics Corp.
Pathology · 9d

About Product Code NPQ - Regulatory Context