Bioplex 2200 Torc Igg
FDA 510(k) K120572 · Bio-Rad Laboratories, Inc.
510(k) numberK120572
Submission
- Device name
- Bioplex 2200 Torc Igg
- Applicant
- Bio-Rad Laboratories, Inc.
Benicia, CA, US - Received
- February 27, 2012
- Decision date
- March 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMI – Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
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.
Other 510(k)s with product code OMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080008 | Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetOMI · Traditional | Bio-Rad Laboratories, Inc. | 02/23/2009SE |
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Questions and answers
When was Bioplex 2200 Torc Igg cleared by the FDA?
Bioplex 2200 Torc Igg (K120572) received a 510(k) decision of Substantially Equivalent on March 26, 2012, 28 days after the submission was received.
What is the product code of K120572?
The FDA product code is OMI – Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv, a Class II (moderate risk) device regulated under 21 CFR 866.3510.