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CEDIA Phencyclidine (PCP) OFT Assay
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 10014888Ref 10018605
Identity
- Trade Name
- CEDIA Phencyclidine (PCP) OFT Assay FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- CEDIA Phencyclidine (PCP) OFT Assay EUDAMEDPCP OFT Assay EUDAMED
- Model / Reference
- 10014888 EUDAMEDFDA UDI10018605 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883011106 EUDAMEDFDA UDI00884883000254 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883011106 EUDAMEDB-00884883000254 EUDAMED
- 510(k) Number
- K101746 FDA UDI
- FDA Product Code
- LCM FDA UDI
- EMDN Code
- W0102090114 PHENCYCLIDINE EUDAMED
- GMDN Term
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDU 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 Phencyclidine (PCP) 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-00884883011106 | 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 db9929f9-64a0-4f33-84ef-0696e475c666 61 fields · synced Jul 30, 2026
- FDA UDI 825414f4-efd7-4b34-96b8-ef35186bae6d 33 fields · synced May 30, 2026
- FDA UDI 6a86e947-3999-461f-b4b9-5eed2742193d 33 fields · synced May 30, 2026
- EUDAMED f3113c74-962f-4272-a6d2-a38ab4324e56 61 fields · synced Jul 30, 2026