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CEDIA Bupernorphine II Assay
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 10020849
Identity
- Trade Name
- CEDIA Bupernorphine II Assay FDA UDI
- Generic Name
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- CEDIA Bupernorphine II Assay EUDAMED
- Model / Reference
- 10020849 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883003873 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883003873 EUDAMED
- 510(k) Number
- K163101 FDA UDI
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090117 BUPRENORPHINE EUDAMED
- GMDN Term
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
CEDIA Bupernorphine II Assay by Microgenics Corporation — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163101 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00884883003873 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (3)
- EUDAMED 6cd5b7f6-4b8f-4c3c-aeb6-d8407f2a34f2 61 fields · synced Jul 10, 2026
- FDA UDI eeb929dc-f887-42b4-8711-bc3b55bd5abb 33 fields · synced May 30, 2026
- FDA 510(k) K163101 1 fields · synced Jun 9, 2026