Kit, Mycoplasma Detection
Mycoplasma Detection Kit is a laboratory device providing reagents and consumables for the detection of mycoplasma contamination in cell cultures, used to verify the absence of these common cell culture contaminants that can adversely affect cell behavior, experimental results, and the safety of biological products derived from those cultures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIW, regulated under 21 CFR 864.2360, within the Hematology medical specialty.
Research product code KIW 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
- KIW
- Device Class
- FDA class 1
- Regulation Number
- 864.2360
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
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 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.