510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NPQClass II

Test, Factor V Leiden Mutations, Genomic Dna Pcr

21 CFR 864.7280 / Hematology
FDA source (opens on fda.gov)

NPQ is the FDA product code for Test, Factor V Leiden Mutations, Genomic Dna Pcr, a class II device type, regulated under 21 CFR 864.7280. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
NPQ
Device name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
FDA definition
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.
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
14

Clearances, product code NPQ

By decision year
6 clearances under product code NPQ with a decision year between 2003 and 2011, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NPQ by decision year
YearClearances
20031
20071
20091
20102
20111

Applicants with the most clearances

Product code NPQ
Applicants holding the most 510(k) clearances under product code NPQ
ApplicantClearances
AutoGenomics, Inc.1
Cepheid1
Hologic, Inc.1
Illumina, Inc.1
Osmetech Molecular Diagnostics1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code