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Lipid Panel, 15ct., CCPlus Home

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
Lipid Panel, 15ct., CCPlus Home FDA UDI
Generic Name
Multiple lipid analyte IVD, kit, spectrophotometry FDA UDI
Device Name
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. FDA UDI
Model / Reference
REF 4753 FDA UDI
Description
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer. FDA UDI

Identifiers

Catalog Number
REF 4753 FDA UDI
Primary DI / UDI-DI
00381934753010 FDA UDI
510(k) Number
K151545 FDA UDI
FDA Product Code
JGY FDA UDI
CHH FDA UDI
LBR FDA UDI
GMDN Term
Multiple lipid analyte IVD, kit, spectrophotometry FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple lipid analyte IVD, kit, spectrophotometry

Lipid Panel, 15ct., CCPlus Home by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple lipid analyte IVD, kit, spectrophotometry.

Cleared under the same submission

K151545 also covers:

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 7d17eaca-d63d-40c7-a4ab-2743e690fa24 37 fields · synced May 30, 2026