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PTS Panels® Triglycerides Test Strips

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
PTS Panels® Triglycerides Test Strips FDA UDI
Generic Name
Triglyceride IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Model / Reference
1716 FDA UDI
Description
PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI

Identifiers

Catalog Number
1716 FDA UDI
Primary DI / UDI-DI
00381931716018 FDA UDI
FDA Product Code
CDT FDA UDI
JGY FDA UDI
GMDN Term
Triglyceride IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1705 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: Triglyceride IVD, kit, rapid colorimetric, clinical

PTS Panels® Triglycerides Test Strips by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 d3b9b6fa-7407-4843-b8fe-4d29b4b244ab 36 fields · synced May 30, 2026