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Dryspot Staphytect Plus
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref DR0100M
by Oxoid Ltd
Identity
- Trade Name
- DRYSPOT STAPHYTECT PLUS EUDAMED
- Device Name
- DRYSPOT STAPHYTECT PLUS EUDAMED
- Model / Reference
- DR0100M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384029297 EUDAMED
- Basic UDI-DI
- 5032384DrySpotStaphySG EUDAMED
- EMDN Code
- W0104080303 STAPHYLOCOCCI SLIDE TESTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Dryspot Staphytect Plus by Oxoid Ltd — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972030 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 5032384DrySpotStaphySG | Class B | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED cd5342df-0544-4f11-8cd4-9e254ba4eb1d 61 fields · synced Jun 18, 2026
- FDA 510(k) K972030 1 fields · synced May 18, 2026