Identity
- Trade Name
- DIASORIN ETI-CORE-IGMK PLUS ASSAY FDA PMA
Identifiers
- PMA Number
- P990044 FDA PMA
Classification
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The ETI-Core-IGMK Plus Assay is an in vitro enzyme immunoassay (EIA) classified under microbiology diagnostics. It is designed for the qualitative detection of immunoglobulin M (IgM) antibodies to hepatitis B core antigen (IgM anti-HBC) in human serum or plasma (collected with EDTA, citrate, or heparin).
This assay is intended for manual use or with the Biochem Immunosystems Labotech/ETI-Lab automated instrument. It is supplied as a single-use diagnostic reagent and is not approved for blood or plasma donor screening. Performance has not been validated for monitoring HBV disease progression or therapy, and additional serological testing is required for definitive disease state classification.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990044 | N/A | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P990044 24 fields · synced Sep 18, 2026