Strep A Rapid Test
by Hangzhou Alltest Biotech.Co., Ltd. 15 variants
Part of a family of 8 devices: see the family page
Ref IST-N501
Strep A Rapid Test (IST-N501) is a Class B device made by Hangzhou Alltest Biotech.Co., Ltd., registered in EUDAMED on 31 Aug 2022 (Basic UDI-DI 6970277510000AXB), active as of 7 Nov 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6970277510000AXB 06936983104388 | Date31 Aug 2022 | StatusActive |
Official records
- EUDAMED public site 6970277510000AXB
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / reference
- IST-N501
- Primary DI / UDI-DI
- 06936983104388
- Basic UDI-DI
- 6970277510000AXB
- EMDN code
- W0105090103 Strep. a - rt & poc
- Device class
- Class B
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000010710
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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