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

C. Difficile Toxin Gene Amplification Assay

21 CFR 866.3130 / Microbiology
FDA source (opens on fda.gov)

OZN is the FDA product code for C. Difficile Toxin Gene Amplification Assay, a class II device type, regulated under 21 CFR 866.3130. FDA's definition for this code reads: "Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
OZN
Device name
C. Difficile Toxin Gene Amplification Assay
FDA definition
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Regulation
21 CFR 866.3130
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
8

Clearances, product code OZN

By decision year
18 clearances under product code OZN with a decision year between 2012 and 2026, 2017 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code OZN by decision year
YearClearances
20122
20134
20141
20151
20175
20212
20231
20251
20261

Applicants with the most clearances

Product code OZN
Applicants holding the most 510(k) clearances under product code OZN
ApplicantClearances
Roche Molecular Systems Inc4
Ortho-Clinical Diagnostics, Inc.3
Luminex Corporation2
Cepheid1
Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC1
Geneohm Sciences Canada, Inc. (BD Diagnostics)1
Genepoc, Inc.1
Intelligent Medical Devices, Inc.1
Primeradx1
Qiagen1

Companies listing this code with FDA

Companies whose registered establishments list this code