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CEDIA Cocaine OFT Assay
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 10018590Ref 10014764
Identity
- Trade Name
- CEDIA Cocaine OFT Assay FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
- Device Name
- CEDIA Cocaine OFT Assay EUDAMED
- Model / Reference
- 10018590 EUDAMEDFDA UDI10014764 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883000223 EUDAMEDFDA UDI00884883011137 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883000223 EUDAMEDB-00884883011137 EUDAMED
- 510(k) Number
- K101742 FDA UDI
- FDA Product Code
- DIO FDA UDI
- EMDN Code
- W0102090106 COCAINE + COCAINE METABOLITES EUDAMED
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3250 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
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 Cocaine OFT Assay by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883000223 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 (4)
- EUDAMED bce0b725-5067-4443-a343-6c16616e18fb 61 fields · synced Jul 14, 2026
- FDA UDI 8b214aa8-89eb-4b08-a1b4-de91f3b11b83 33 fields · synced May 29, 2026
- FDA UDI a3bd3bb1-37c3-4bc9-a0e5-2d34ac9d9608 33 fields · synced May 30, 2026
- EUDAMED 8af51763-c361-4457-abc3-960c457f156d 61 fields · synced Jul 11, 2026