QYAClass II
System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home
Microbiology · 21 CFR 866.3385
This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.
MDR events0All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
2 clearances for this product code