Skip to content

Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry 10315660

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 Number00630414479095 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  • Withdrawn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
Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
10315660, 5085
Primary DI / UDI-DI
00630414479095
510(k) Number
FDA Product Code
CEN, JIL, LJX, KQO, JIN, JRE, JFY, JIP, CDM, JIR, JJB, JMT
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Device Class
Class I
Regulation Number
862.1550, 862.1340, 864.7675, 862.2900, 862.1435, 862.2800, 862.1225, 864.6550, 862.1785, 862.1645, 862.1115, 862.1510
GUDID distribution status
In Commercial Distribution

Related devices

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

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • Sterile: No
  • Single Use: 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