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TestPack Plus Strep A with OBC
EUDAMEDClass IVD General (EU MDR)
Ref 505715JModel TestPack Plus Strep A with OBC
Identity
- Trade Name
- TestPack Plus Strep A with OBC EUDAMED
- Device Name
- TestPack Plus Strep A with OBC EUDAMED
- Model / Reference
- TestPack Plus Strep A with OBC EUDAMED505715J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571226471784 EUDAMED
- Basic UDI-DI
- B-04571226471784 EUDAMED
- EMDN Code
- W0105090103 STREP. A - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
TestPack Plus Strep A with OBC by Abbott Diagnostics Medical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04571226471784 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Medical Co., Ltd.
- EUDAMED SRN
- JP-MF-000009543
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 85c31b12-6b4b-4ddf-990f-b2beb68fa75c 61 fields · synced May 23, 2026