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CardioChek 5700534

by Henry Schein, Inc.

CardioChek 5700534 is a Class I device made by Henry Schein, Inc., listed in FDA GUDID since 16 Jan 2017 (UDI-DI 00304040040539), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00304040040539 UDI-DI Date16 Jan 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  • Withdrawn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
CardioChek
Generic name
Multiple clinical chemistry enzyme IVD, kit, spectrophotometry
Model / Ref / Catalog
5700534
Primary DI / UDI-DI
00304040040539
FDA product code
GIO, NBW, LBR, JGY, JJY, CGA, CHH
GMDN term
Multiple clinical chemistry enzyme IVD, kit, spectrophotometry
Device class
Class I
Regulation number
864.6150, 862.1345, 862.1475, 862.1705, 862.1660, 862.1175
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple-type clinical chemistry analyte profile IVD, controlMultiple clinical chemistry analyser IVD, point-of-careCapillary blood collection tube IVD, no additiveMultiple lipid analyte IVD, kit, multiple technologies

Similar devices

Other devices filed under FDA product code GIO (TUBE, COLLECTION, CAPILLARY BLOOD).

Other devices from Henry Schein, Inc.

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Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (10, all answered No)