Identity
- Trade Name
- BACTICARD STREP EUDAMEDBACTICARD FDA UDI
- Generic Name
- Bacterial species differentiation disc IVD FDA UDI
- Device Name
- BACTICARD STREP EUDAMEDBactiCard Strep 25TST/KT FDA UDI
- Model / Reference
- R21112 EUDAMEDFDA UDI
- Description
- BactiCard Strep 25TST/KT FDA UDI
Identifiers
- Catalog Number
- R21112 FDA UDI
- Primary DI / UDI-DI
- 00848838022494 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380BactiCardStrep3A EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080203 GRAM POSITIVE - MANUAL IDENTIFICATION EUDAMED
- GMDN Term
- Bacterial species differentiation disc IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bacticard Strep by Remel, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8488380BactiCardStrep3A | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 2dd997aa-8cfb-4a25-8a84-2105bf1c3344 61 fields · synced Jun 19, 2026
- FDA UDI 3682f232-511d-4d21-a913-6d67a12d8f31 34 fields · synced May 30, 2026