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PTS Panels® CHOL+Glu Test Strips

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
PTS Panels® CHOL+Glu Test Strips FDA UDI
Generic Name
Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
Device Name
PTS Panels® CHOL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Model / Reference
1765 FDA UDI
Description
PTS Panels® CHOL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI

Identifiers

Catalog Number
1765 FDA UDI
Primary DI / UDI-DI
00381931765016 FDA UDI
510(k) Number
K162282 FDA UDI
FDA Product Code
CHH FDA UDI
NBW FDA UDI
CGA FDA UDI
GMDN Term
Multiple lipid analyte IVD, kit, multiple technologies FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1175 FDA UDI
862.1345 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+Glu Test Strips 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, 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 c8079779-9dd4-4a8a-bcd1-fbf1170bf853 37 fields · synced Jun 1, 2026