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Uristix® Reagent Strips 10339520

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00630414549132 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Uristix® Reagent Strips
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
10339520, A2184B16
Primary DI / UDI-DI
00630414549132
510(k) Number
FDA Product Code
CDM, JIO, JJB, CEN, JIL, JRE, JIN, JIR, LJX, JMT, JFY
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device Class
Class I
Regulation Number
862.1785, 864.6550, 862.1115, 862.1550, 862.1340, 862.2800, 862.1435, 862.1645, 864.7675, 862.1510, 862.1225
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Cleared under the same submission (K992257)

Show all (12)

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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