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Ca Cal S 01412714

by Sysmex Corporation

Ca Cal S 01412714 is a Class II device made by Sysmex Corporation, listed in FDA GUDID since 6 Oct 2017 (UDI-DI 04987562205936), registry data as of 12 Nov 2026.

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

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987562205936 UDI-DI Date6 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ca Cal S
Generic name
Multiple coagulation marker IVD, calibrator
Model / reference
01412714
Primary DI / UDI-DI
04987562205936
FDA product code
GKP
GMDN term
Multiple coagulation marker IVD, calibrator
Device class
Class II
Regulation number
864.5400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple coagulation factor IVD, calibrator

Similar devices

Other devices filed under FDA product code GKP (INSTRUMENT, COAGULATION, AUTOMATED).

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)