Identity
- Trade Name
- EDDP CONTROL 1 FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control FDA UDI
- Device Name
- The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP. FDA UDI
- Model / Reference
- DA3123 FDA UDI
- Description
- The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP. FDA UDI
Identifiers
- Catalog Number
- DA3123 FDA UDI
- Primary DI / UDI-DI
- 05055273207910 FDA UDI
- 510(k) Number
- K092258 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control
Eddp Control 1 by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092258 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI a51e54c8-b020-4d74-8a60-57cd6425a465 37 fields · synced May 31, 2026