OPM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- FDA definition
- The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors.
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| Record | Firm | Date |
|---|---|---|
| ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM (K093784) | Zeus Scientific, Inc. | 2010-07-16 |
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Every clearance here is in the API, with alerts when new ones post.