AmniSure ROM Test

Placental alpha microglobulin-1 (PAMG-1) · class II · Valid

Registration no.
10322250140
Process no.
25351132652202609
Status
Valid
Device type
Placental alpha microglobulin-1 (PAMG-1) (ALFA-MICROGLOBULINA-1 PLACENTÁRIA (PAMG-1))
Risk class
II
Registration holder
QIAGEN BIOTECNOLOGIA BRASIL LTDA. CNPJ 01.334.250/0001-20 · 154 registrations
Manufacturer
QIAGEN · United States
Published
31/08/2026
Valid until
No expiry (VIGENTE)
Last updated by ANVISA
2026-10-12
Official record
View on ANVISA ↗

Other placental alpha microglobulin-1 (pamg-1) registrations (3 in total, see all)

ProductClass HolderPublishedStatus
PartoSure Test
10322250136
II QIAGEN BIOTECNOLOGIA BRASIL LTDA. 18/08/2025 Valid
AmniSure – Teste para Detecção de Ruptura de Membrana Fetal
10322250050
II QIAGEN BIOTECNOLOGIA BRASIL LTDA. 02/09/2013 Valid