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GEM Check Coag Control-Normal for PT 06260060400

by Instrumentation Laboratory Company

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

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 Number08426950452737 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2107-2010 FDA Unclassified (pre-2012) initiated 8 Jul 2010
    • Terminated Z-2108-2010 FDA Unclassified (pre-2012) initiated 8 Jul 2010

    Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.

    • Terminated Z-2200-2010 FDA Unclassified (pre-2012) initiated 25 Jun 2010

    The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes

    • Terminated Z-1786-2010 FDA Unclassified (pre-2012) initiated 15 Apr 2010

    Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GEM Check Coag Control-Normal for PT
Generic Name
Multiple coagulation marker IVD, control
Model / Ref / Catalog
06260060400
Primary DI / UDI-DI
08426950452737
510(k) Number
FDA Product Code
GGN
GMDN Term
Multiple coagulation marker IVD, control
Device Class
Class II
Regulation Number
864.5425
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K944691)

Show all (9)

Other devices from Instrumentation Laboratory Company

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No