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Eddp DA4013

by Randox Laboratories, Ltd.

Eddp DA4013 is a 2-ethylidine-1 (FDA Class II; FDA product code DJR, Enzyme Immunoassay, Methadone) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K092258 on 9 Nov 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273208061), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K092258

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055273208061 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092258 Date9 Nov 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092258 decided 9 Nov 2010 Active
  • FDA GUDID UDI-DI 05055273208061 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092258
  2. Listed FDA GUDID 05055273208061

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Eddp
Generic name
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent
Model / Ref / Catalog
DA4013
Primary DI / UDI-DI
05055273208061
510(k) Number
FDA product code
DJR
GMDN term
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent
Device class
Class II
Regulation number
862.3620
GUDID distribution status
In Commercial Distribution

Related devices

Category: 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent

Cleared under the same submission (K092258)

Similar devices

Other devices filed under FDA product code DJR (Enzyme Immunoassay, Methadone).

Other devices from Randox Laboratories, Ltd.

See all devices from Randox Laboratories, Ltd. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)