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CardioChek Plus Home Self-Test Analyzer

FDA UDI

Class II (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
CardioChek Plus Home Self-Test Analyzer FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Device Name
The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen. FDA UDI
Model / Reference
4720 FDA UDI
Description
The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen. FDA UDI

Identifiers

Catalog Number
4720 FDA UDI
Primary DI / UDI-DI
00381934720012 FDA UDI
FDA Product Code
NBW FDA UDI
JGY FDA UDI
CGA FDA UDI
LBR FDA UDI
CHH FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1705 FDA UDI
862.1475 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyser IVD, point-of-care

CardioChek Plus Home Self-Test Analyzer by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, point-of-care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polymer Technology Systems

Sources (1)

  • FDA UDI 15a0b697-5b6e-454a-9b48-40e045272339 36 fields · synced May 30, 2026