← Back to catalogue
Signal Blood Culture System
EUDAMEDFDA UDIClass C (EU MDR)
Ref BC0100M
by Oxoid Ltd
Identity
- Trade Name
- SIGNAL BLOOD CULTURE SYSTEM EUDAMEDSIGNAL BLOOD CULTURE SYSTEM 1 X 20 FDA UDI
- Generic Name
- Blood culture broth kit IVD FDA UDI
- Device Name
- SIGNAL BLOOD CULTURE SYSTEM EUDAMED
- Model / Reference
- BC0100M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384013623 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SignalBCDK EUDAMED
- 510(k) Number
- K862946 FDA UDI
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W0104010501 BOTTLES FOR MANUAL BLOOD CULTURE EUDAMED
- GMDN Term
- Blood culture broth kit IVD FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2300 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
Yes
EUDAMED
Microbial Substances
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Signal Blood Culture System by Oxoid Ltd — Class C — 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 | 5032384SignalBCDK | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED ccc7e878-8d8e-41d5-915d-28f099abf8f2 61 fields · synced Jul 16, 2026
- FDA UDI 1ff10dad-0613-4232-9f37-59c6e728442a 33 fields · synced May 30, 2026