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AutoUA® 200-60

by SCITECK Diagnostics

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00854080008629 UDI-DI Date7 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AutoUA®
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
200-60
Primary DI / UDI-DI
00854080008629
510(k) Number
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
GUDID distribution status
In Commercial Distribution

Related devices

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Cleared under the same submission (K954514)

Cleared under the same submission (K970087)

Other devices from SCITECK Diagnostics

Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No