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Dimension Vista® Flex® reagent cartridge HbA1c KIT 10470481

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 Number00842768029974 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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 HbA1c KIT
Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10470481, K3105A
Primary DI / UDI-DI
00842768029974
FDA Product Code
JIT, LCP
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
862.1150, 864.7470
GUDID distribution status
Not in Commercial Distribution

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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