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Discover DIS-DIP-484SP

by American Screening, L.L.C. 2 variants

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 23 Oct 2026

Documents

510(k) K180349

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840050504154 UDI-DI Date11 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180349 Date5 Apr 2018DecidedStatusActive

Official records

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Discover
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference
DIS-DIP-484SP
Primary DI / UDI-DI
00840050504154
FDA product code
PTG, NGG, NFW, NGL, NFY, NFT, NGM, QAW, PTH, QBF, NFV
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3620, 862.3610, 862.3870, 862.3650, 862.3250, 862.3100, 862.3910, 862.3150, 862.3700, 862.3170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Cleared under the same submission (K180349)

Show all (12)

Other devices from American Screening, L.L.C.

See all devices from American Screening, L.L.C. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No