DeviceClearance

Product code MKZ— Microbiology

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

Classification name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Device class
Class 1
Regulation
21 CFR 866.3120
Advisory panel
Microbiology
Total cleared
19
First cleared
Most recent

Market context for product code MKZ

FDA has cleared 19 devices under product code MKZ between 1993 and 2023, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code MKZ

Recent clearances under product code MKZ

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