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PTS Panels® CHOL+HDL+GLU Test Strips

FDA UDI

Class II (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
PTS Panels® CHOL+HDL+GLU Test Strips FDA UDI
Generic Name
Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
Device Name
PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL Cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer. FDA UDI
Model / Reference
2412 FDA UDI
Description
PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL Cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer. FDA UDI

Identifiers

Catalog Number
2412 FDA UDI
Primary DI / UDI-DI
00381932412018 FDA UDI
510(k) Number
K162282 FDA UDI
FDA Product Code
CGA FDA UDI
LBR FDA UDI
CHH FDA UDI
NBW FDA UDI
GMDN Term
Multiple lipid analyte IVD, kit, multiple technologies FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple lipid analyte IVD, kit, multiple technologies

PTS Panels® CHOL+HDL+GLU Test Strips by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple lipid analyte IVD, kit, multiple technologies.

Cleared under the same submission

K162282 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 3cd28941-7570-4e1a-960b-9f9dff557a45 37 fields · synced May 30, 2026