510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OZZClass II

Bordetella Pertussis Dna Assay System

21 CFR 866.3980 / Microbiology
FDA source (opens on fda.gov)

OZZ is the FDA product code for Bordetella Pertussis Dna Assay System, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting...". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OZZ
Device name
Bordetella Pertussis Dna Assay System
FDA definition
A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Regulation
21 CFR 866.3980
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
9
Ingested recalls
2

Clearances, product code OZZ

By decision year
9 clearances under product code OZZ with a decision year between 2014 and 2025, 2018 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OZZ by decision year
YearClearances
20142
20151
20172
20183
20251

Applicants with the most clearances

Product code OZZ
Applicants holding the most 510(k) clearances under product code OZZ
ApplicantClearances
DiaSorin Molecular LLC2
Meridian Bioscience Inc2
Ortho-Clinical Diagnostics, Inc.2
Great Basin Scientific, Inc.1
Luminex Corporation1
Roche Molecular Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code