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

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

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

NPR is the FDA product code for Test, Factor Ii G20210a 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 II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NPR
Device name
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
FDA definition
In vitro diagnostic test to detect the Factor II G20210A 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
5
Ingested recalls
2

Clearances, product code NPR

By decision year
5 clearances under product code NPR with a decision year between 2003 and 2025, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NPR by decision year
YearClearances
20031
20111
20181
20231
20251

Applicants with the most clearances

Product code NPR
Applicants holding the most 510(k) clearances under product code NPR
ApplicantClearances
Cepheid2
Hologic, Inc.1
Roche Diagnostics GmbH1
Roche Molecular Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code