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Dimension Vista® System PSA CAL 10464359

by Siemens Healthcare Diagnostics Inc.

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

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 Number00842768024214 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: 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  • Withdrawn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® System PSA CAL
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / Ref / Catalog
10464359, KC602
Primary DI / UDI-DI
00842768024214
FDA Product Code
MTG
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class III
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Contains Latex
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: 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