ERIS CircularCircular Normativa n.º 001/ERIS-DRS/2021
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Circular Normativa n.º 001/ERIS-DRS/2021 is the official ERIS identifier for “Certificação de laboratórios para testes rápidos de anticorpos e antigénio SARS-CoV-2”. Circular Normativa n.º 001/ERIS-DRS/2021 is the official identifier ERIS uses for this instrument.
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Certificação de laboratórios para testes rápidos de anticorpos e antigénio SARS-CoV-2
Complete six-page circular including all four pages of its integral laboratory safety annex. Data 15 February 2021 is issuance only; formal publication and effective dates are unverified. Requires prior ERIS laboratory service certification; antigen testing adds a premises/flow-plan document to the three antibody-test documents. Preserves staffing, biosafety, sampling, waste and reporting guidance. Its Resolution 169/2020 reference is not treated as proof of a current authorization: that original has a thirty-day term, and separately retained Resolutions 4/2021 and 20/2021 concern emergency-state and facility measures without themselves repeating the antigen-test authorization. Further legal continuity and present applicability remain under review. Waste-handling periods are not approval SLAs. This is laboratory-service certification, not a general IVD product modification process; later changes remain open.
Circular Normativa n.º 001/ERIS-DRS/2021 is the official identifier ERIS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.