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Strep A Rapid Test Cassette
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref IST-502510(k) K260342
Identity
- Device Name
- Strep A Rapid Test Cassette EUDAMED
- Model / Reference
- IST-502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970277510493 EUDAMED
- Basic UDI-DI
- B-06970277510493 EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Strep A Rapid Test Cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260342 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970277510493 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- FDA Applicant
- Hangzhou AllTest Biotech Co., Ltd.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED ba0e435a-2ea6-4cf4-a367-8b9286613767 85 fields · synced Jun 18, 2026
- FDA 510(k) K260342 1 fields · synced May 18, 2026