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Dimension Vista® Flex® reagent cartridge LIPL 10461745

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842768020223 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dimension Vista® Flex® reagent cartridge LIPL
Generic Name
Lipase IVD, kit, spectrophotometry
Model / Ref / Catalog
10461745, K3056
Primary DI / UDI-DI
00842768020223
FDA Product Code
CHI
GMDN Term
Lipase IVD, kit, spectrophotometry
Device Class
Class I
Regulation Number
862.1465
GUDID distribution status
Not in Commercial Distribution

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Serial Number: No
  • Manufacturing Date: No