ANVISA registration

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

Registration 82444370217. PARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III

Registration details

Registration number82444370217
Application number25351381438202412
Technical namePARÂMETROS COMBINADOS NO MESMO PRODUTO - CLASSE III
Risk classIII
Published on31/03/2025
ValidityValid until 31/03/2035

Registration holder

Legal nameEnzytec Biotecnologia Ltda.
CNPJ07.214.566/0001-65

Manufacturer

  • ZHEJIANG ORIENT GENE BIOTECH CO., LTD. CHINA, REPÚBLICA POPULAR

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Alethia Instrument

82444370001

m-prep

82444370002

Alethia Strep Grupo B Controles Externos

82444370006

Alethia Mycoplasma Direto Controle Externo

82444370007

Alethia Pertussis Controle Externo

82444370008

Alethia Strep Grupo A

82444370009

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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