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New Choice 45001

by SCI Medic, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00677421450013 UDI-DI Date26 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
New Choice
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Reference
45001
Primary DI / UDI-DI
00677421450013
FDA Product Code
JMT, LJX
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device Class
Class I
Regulation Number
862.1510, 864.7675
GUDID distribution status
In Commercial Distribution

Other devices from SCI Medic, Inc.

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No