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Na 301-3

by Alta Diagnostics, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10858512007065 UDI-DIDate29 Mar 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multiple urine analyte IVD, control
Model / Ref / Catalog
301-3
Primary DI / UDI-DI
10858512007065
510(k) Number
FDA Product Code
JJW
GMDN Term
Multiple urine analyte IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 250 Milliliter

Related devices

Category: Multiple urine analyte IVD, control

Cleared under the same submission (K890577)

Show all (12)

Other devices from Alta Diagnostics, Inc.

See all devices from Alta Diagnostics, Inc. →

Properties

  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No