Identity
- Trade Name
- DRI Cotinine Low Control FDA UDI
- Generic Name
- Cotinine (nicotine metabolite) IVD, control FDA UDI
- Device Name
- DRI Cotinine Low Control EUDAMED
- Model / Reference
- 0460 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001077 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883001077 EUDAMED
- FDA Product Code
- MKU FDA UDI
- EMDN Code
- W0102090108 COTININE EUDAMED
- GMDN Term
- Cotinine (nicotine metabolite) IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3220 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
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DRI Cotinine Low Control 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-00884883001077 | 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 (2)
- EUDAMED c2204388-431d-4681-8c83-0fc317bfc86c 61 fields · synced Jul 27, 2026
- FDA UDI 64625076-ce16-4078-a641-9350e4dc81e5 32 fields · synced May 30, 2026