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Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test CS3002

by International Point of Care Incorporated 3 variants

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 NumberB103A25CS30021 UDI-DI Date15 Sep 2016ListedStatusListed 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  • Withdrawn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 Myoglobin/Troponin I/CK-MB Tandem Test
Generic Name
Multiple cardiac marker IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
CS3002
Primary DI / UDI-DI
B103A25CS30021
510(k) Number
FDA Product Code
DEA, MMI, JHT
GMDN Term
Multiple cardiac marker IVD, kit, rapid ICT, clinical
Device Class
Class II
Regulation Number
866.5680, 862.1215
GUDID distribution status
Not in Commercial Distribution

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