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TRUEplus Ketone Test Strips

by Trividia Health, Inc.

TRUEplus Ketone Test Strips is a Class I device made by Trividia Health, Inc., listed in FDA GUDID since 21 Oct 2020 (UDI-DI 00021292008178), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00021292008178 UDI-DI Date21 Oct 2020ListedStatusListed GUDID: 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  • Withdrawn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
TRUEplus
Generic name
Urine ketone IVD, kit, rapid colorimetric, clinical
Model / reference
TRUEplus Ketone Test Strips
Primary DI / UDI-DI
00021292008178
FDA product code
JIN
GMDN term
Urine ketone IVD, kit, rapid colorimetric, clinical
Device class
Class I
Regulation number
862.1435
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: TRUEplus® Ketone Test Strips

Related devices

Category: Urine ketone IVD, kit, rapid colorimetric, clinical

Similar devices

Other devices filed under FDA product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)).

Other devices from Trividia Health, Inc.

See all devices from Trividia Health, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)