Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
- US Product Code (FDA)
- OPMView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3510View CFR Regulation →
- Medical specialty
- Microbiology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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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Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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