Família MassScreen Amino Acids, Acylcarnitines EXTENDED (non-derivatised) incl. Ado, dAdo

Combined parameters in one product (III) - newborn screening · class III · Until 29/12/2035

Registration no.
10350840489
Process no.
25351180164202519
Status
Until 29/12/2035
Device type
Combined parameters in one product (III) - newborn screening (PARÂMETROS COMBINADOS NO MESMO PRODUTO (III) - TRIAGEM NEONATAL)
Risk class
III
Registration holder
BIOSYS LTDA CNPJ 02.220.795/0001-79 · 506 registrations
Manufacturer
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH · Germany
Published
29/12/2025
Valid until
29/12/2035
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)

ProductClass HolderPublishedStatus
FAMÍLIA BIO GENE DBS SCID / AME PCR
10269360472
III QUIBASA - QUIMICA BASICA LTDA 07/07/2025 Until 07/07/2035
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