510(k) K080008
K080008 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code OMI (Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv), a Class II device regulated under 21 CFR 866.3510. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2009
- Date Received
- January 2, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type
The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.