DeviceClearance

Product code OZZ— Microbiology

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

Classification name
Bordetella Pertussis Dna Assay System
Device class
Class 2
Regulation
21 CFR 866.3980
Advisory panel
Microbiology
Total cleared
9
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OZZ under 21 CFR 866.3980, via openFDA

Market context for product code OZZ

FDA has cleared 9 devices under product code OZZ between 2014 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OZZ

Recent clearances under product code OZZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.