PUQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (K170509) | Bio-Rad Laboratories | 2017-05-19 | + Add |
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