PUQ — Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm Class II
Classification Details
- Product Code
- PUQ
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170509 | bio-rad laboratories | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC I | May 19, 2017 |