International safety notice
Technical name: ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUS (HCV AG/ANTI-HCV)
Brazil / Anvisa · BRA · May 19, 2017
Key facts
| Title | Technical name: ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUS (HCV AG/ANTI-HCV) |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Monolisa HCV Ag-Ab ULTRA V2 Technical name: ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUS (HCV AG/ANTI-HCV) ANVISA registration number: 80020690319 Risk class: IV Affected model: 480 tests / 96 tests Numbers of Affected series: 6J0533, 6K0535, 6M0536 and 6K0534 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIORAD LABORATÓRIOS BRASIL LTDA CNPJ 03188198000177 ENDEREÇO RUA ALFREDO ALBANO DA COSTA 100 SALAS 1 2 E 3 MUNICÍPIO LAGOA SANTA UF MG TELEFONE DE CONTATO 0800 200 8900 FABRICANTE BIORAD ENDEREÇO 3 BOULEVARD RAYMOND POINCARÉ 92430 MUNICÍPIO MARNESLACOQUETTE PAÍS FRANÇA |
| Models | 6M0536, 6J0533, 6K0535, 6K0534, 80020690319 |
| Date | May 19, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1