HSA · registration DE0508245Abbott ARCHITECT HSV-2 IgG
- Registration number
- DE0508245
- Model name
- ARCHITECT HSV-2 IgG Calibrator; ARCHITECT HSV-2 IgG Controls; ARCHITECT HSV-2 IgG; ARCHITECT HSV-2 IgG
- Model identifier
- 04U6001; 04U6010; 04U6025; 04U6035
- Registration date
- June 27, 2023
- Risk class
- Class C
- Product owner
- Abbott Ireland Diagnostics Division
- Registrant / registration holder
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
The HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative determination of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma on the ARCHITECT i System. The HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The HSV-2 IgG assay is to be used as an aid in the determination of immune status and as an aid in the diagnosis of HSV infection in individuals including expectant mothers. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. NOTE: The performance of the HSV-2 IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised or immunosuppressed patients.
- Product owner address
- Finisklin Business Park, Sligo, Ireland
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.