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Direct Lipid Control Set 3000

by Medtest DX

Direct Lipid Control Set 3000, a multiple lipid analyte IVD (FDA Class I; FDA product code JJY, Multi-Analyte Controls, All Kinds (Assayed)) made by Medtest DX, was listed in FDA GUDID on 27 Sep 2016 (UDI-DI 00817439020000); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817439020000 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Direct Lipid Control Set
Generic name
Multiple lipid analyte IVD, control
Model / Ref / Catalog
3000
Primary DI / UDI-DI
00817439020000
FDA product code
JJY
GMDN term
Multiple lipid analyte IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

Other devices from Medtest DX

See all devices from Medtest DX →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)