Aso
Ref 22122
Aso (22122) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category anti-streptolysin o reaction time / titre (qualitative)) made by Cypress Diagnostics, registered in EUDAMED on 7 Apr 2026 (Basic UDI-DI B-05404035101964), active as of 22 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05404035101964 05404035101964 | Date7 Apr 2026 | StatusActive |
Official records
- EUDAMED public site B-05404035101964
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / reference
- 22122
- Primary DI / UDI-DI
- 05404035101964
- Basic UDI-DI
- B-05404035101964
- EMDN code
- W01021105 Anti-streptolysin o reaction time / titre (qualitative)
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000000033
Similar devices in this category
Other devices filed under RHEUMATOID - INFLAMMATORY DISEASES MARKERS.
- rheumajet ASO 3000-7010 by BIOKIT, S.A.
- Antistreptolysin O Titre (ASOT) 510 002 by Egyptian Company For Biotechnology-Spectrum Diagnostics
- ASO lateks bez kontr 100 ozn 1-901-1001 by BioMaxima Spółka Akcyjna
- Atellica CH Anti-Streptolysin-O_3 (ASO_3) 11537212 by Siemens Healthcare Diagnostics Inc.
- ADVIA® Chemistry Wide Range C-Reactive Protein Reagents 10341101 829585 by Siemens Healthcare Diagnostics Inc.
- ASO 1418-1065 by Medicon Hellas SA
- C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric) by Biobase Biodustry(Shandong) Co.,Ltd.
- ASO 1419-1066 by Medicon Hellas SA
- Anti-Streptolysin O (ASO) Calibrator ECH0182301 by Maccura Biotechnology Co., Ltd.
- C-REACTIVE PROTEIN REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY) 3009265 by DIRUI INDUSTRIAL CO., LTD