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Scantibodies Laboratory, Inc. 3KG556

by Scantibodies Laboratory 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850002253153 UDI-DI Date20 May 2019ListedStatusListed 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  • Withdrawn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
Scantibodies Laboratory, Inc.
Generic Name
Calcitonin IVD, kit, enzyme immunoassay (EIA)
Model / Reference
3KG556
Primary DI / UDI-DI
00850002253153
FDA Product Code
JKR
GMDN Term
Calcitonin IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
862.1140
GUDID distribution status
Not in Commercial Distribution

Other devices from Scantibodies Laboratory Inc.

See all devices from Scantibodies Laboratory Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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