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Dimension® CSAE Calibrator 10445004

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00842768018213 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Dimension® CSAE Calibrator
Generic Name
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
10445004, DC108A
Primary DI / UDI-DI
00842768018213
510(k) Number
FDA Product Code
DLJ
GMDN Term
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Device Class
Class II
Regulation Number
862.3200
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Contains Latex
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: 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