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CardioChek

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
CardioChek FDA UDI
Generic Name
Multiple clinical chemistry enzyme IVD, kit, spectrophotometry FDA UDI
Device Name
CardioChek Plus Analyzer Starter Pack FDA UDI
Model / Reference
5700534 FDA UDI
Description
CardioChek Plus Analyzer Starter Pack FDA UDI

Identifiers

Catalog Number
5700534 FDA UDI
Primary DI / UDI-DI
00304040040539 FDA UDI
FDA Product Code
GIO FDA UDI
NBW FDA UDI
LBR FDA UDI
JGY FDA UDI
JJY FDA UDI
CGA FDA UDI
CHH FDA UDI
GMDN Term
Multiple clinical chemistry enzyme IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.6150 FDA UDI
862.1345 FDA UDI
862.1475 FDA UDI
862.1705 FDA UDI
862.1660 FDA UDI
862.1175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

CardioChek by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry enzyme IVD, kit, spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI c22c60d5-2b27-4e28-9016-e61c6e01d5e0 35 fields · synced May 30, 2026