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CEDIA Amphetamine OFT Assay_LC
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 10021729Ref 10014947
Identity
- Trade Name
- CEDIA Amphetamine OFT Assay FDA UDI
- Generic Name
- Amphetamine-specific IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- CEDIA Amphetamine OFT Assay_LC EUDAMEDCEDIA Amphetamine OFT Assay EUDAMED
- Model / Reference
- 10021729 EUDAMEDFDA UDI10014947 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883000841 EUDAMEDFDA UDI00884883011069 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883000841 EUDAMEDB-00884883011069 EUDAMED
- 510(k) Number
- K101745 FDA UDI
- FDA Product Code
- DKZ FDA UDI
- EMDN Code
- W0102090101 AMPHETAMINES GROUP EUDAMED
- GMDN Term
- Amphetamine-specific IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3100 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 Amphetamine OFT Assay_LC 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-00884883000841 | 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 62cf0ffb-06b6-45b8-ab85-85a9d1f41bc0 61 fields · synced Sep 18, 2026
- FDA UDI 76e8f78b-2a4a-4f3d-9cad-c8f044be6e34 33 fields · synced May 30, 2026
- FDA UDI 6fcc2acb-27ad-4123-805f-2c83b8cfc9c6 33 fields · synced May 30, 2026
- EUDAMED af9794a3-2744-4342-b00a-e88e92b67699 61 fields · synced Jul 12, 2026