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Uric Acid ver.2 08058750190

by Roche Diagnostics GmbH

Uric Acid ver.2 08058750190 is a Class I device made by Roche Diagnostics GmbH, listed in FDA GUDID since 5 Mar 2020 (UDI-DI 07613336121580), registry data as of 12 Nov 2026.

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

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613336121580 UDI-DI Date5 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Uric Acid ver.2
Generic name
Uric acid IVD, kit, spectrophotometry
Model / Ref / Catalog
08058750190
Primary DI / UDI-DI
07613336121580
FDA product code
KNK
GMDN term
Uric acid IVD, kit, spectrophotometry
Device class
Class I
Regulation number
862.1775
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)