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Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) CSC3023

by International Point of Care Incorporated

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberB103CSC30231 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)
Generic Name
Multiple cardiac marker IVD, control
Model / Ref / Catalog
CSC3023
Primary DI / UDI-DI
B103CSC30231
510(k) Number
FDA Product Code
JJY
GMDN Term
Multiple cardiac marker IVD, control
Device Class
Class I
Regulation Number
862.1660
GUDID distribution status
Not in Commercial Distribution

Properties

Other properties (14)

  • Sterile: No
  • Single Use: 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No