Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
The Multiplex Flow Immunoassay, T. Gondii, Rubella, CMV IgM is a microbiology diagnostic kit used for the simultaneous qualitative detection of IgM antibodies to Toxoplasma gondii, Rubella, and Cytomegalovirus (CMV) in human serum and plasma, aiding in the diagnosis of these TORCH infections particularly in pregnant women or immunocompromised patients. It is classified as FDA Class II under regulation 21 CFR 866.3510, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PUQ and it falls under the Microbiology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUQ
- Device Class
- FDA class 2
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | May 19, 2017 | Substantially Equivalent | Bio-Rad Laboratories |
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.