System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
The system for detection of nucleic acid from non-viral microorganisms causing STIs using specimens collected at home (product code QYA) is a Class 2 Microbiology in vitro diagnostic device (regulation 866.3385) intended for self-collection of specimens in home settings, with subsequent laboratory testing for detection of nucleic acids from non-viral sexually transmitted infection pathogens to aid in diagnosis. It requires 510(k) clearance and may be used for prescription or over-the-counter purposes. It is not an implant and is not life-sustaining.
Research product code QYA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QYA
- Device Class
- FDA class 2
- Regulation Number
- 866.3385
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.