FAMÍLIA BIO GENE DBS SCID / AME PCR
Combined parameters in one product (III) - newborn screening · class III · Until 07/07/2035
- Registration no.
- 10269360472
- Process no.
- 25351036996202507
- Status
- Until 07/07/2035
- Device type
- Combined parameters in one product (III) - newborn screening (PARÂMETROS COMBINADOS NO MESMO PRODUTO (III) - TRIAGEM NEONATAL)
- Risk class
- III
- Registration holder
- QUIBASA - QUIMICA BASICA LTDA CNPJ 19.400.787/0001-07 · 509 registrations
- Manufacturer
- Published
- 07/07/2025
- Valid until
- 07/07/2035
- Last updated by ANVISA
- 2026-10-12
- Official record
- View on ANVISA ↗
Other combined parameters in one product (iii) - newborn screening registrations (7 in total, see all)
| Product | Class | Holder | Published | Status |
|---|---|---|---|---|
| Família MassScreen Amino Acids, Acylcarnitines EXTENDED (non-derivatised) incl. Ado, dAdo
10350840489 |
III | BIOSYS LTDA | 29/12/2025 | Until 29/12/2035 |
| Kit Eonis™ SCID-SMA PN: 3241-0020
10298910182 |
III | REVVITY DO BRASIL LTDA | 20/05/2024 | Until 20/05/2034 |
| Kit de detecção NeoScreen PCR SMA/TREC/KREC em tempo real
82149920063 |
III | GENESTAR INOVAÇÕES E EQUIPAMENTOS MÉDICOS LTDA | 26/12/2023 | Until 26/12/2033 |
| Eonis™ SCID-SMA kit PN 3241-0010/ PN 3242-0010
10298910155 |
III | REVVITY DO BRASIL LTDA | 03/05/2021 | Until 03/05/2031 |
| Kit NeoMAP® 4PLEX H
80173700014 |
III | INTERNACIONAL CIENTIFICA LTDA | 11/04/2011 | Until 11/04/2036 |
| NeoBase Non-Derivatized MSMS Kit
10298910097 |
III | REVVITY DO BRASIL LTDA | 13/04/2009 | Until 13/04/2034 |