ANVISA registration

DETECT SARS-CoV-2 RT-PCR

Registration 10009010357. CORONAVÍRUS

Registration details

Registration number10009010357
Application number25351269839202063
Technical nameCORONAVÍRUS
Risk classIII
Published on27/04/2020
ValidityValid until 27/04/2030

Registration holder

Legal nameLABTEST DIAGNOSTICA S/A
CNPJ16.516.296/0001-38

Manufacturer

  • LABTEST DIAGNOSTICA S/A BRASIL

Source: ANVISA

Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this registration may have been cancelled before its expiry date without this being shown here. Before making purchasing, import or marketing decisions, check the ANVISA search portal.

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Medical device registration with ANVISA

HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.

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