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Cholesterol

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
Cholesterol FDA UDI
Generic Name
Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing FDA UDI
Device Name
PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood from the fingertip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This system is intended for self-testing use. FDA UDI
Model / Reference
REF 4770 FDA UDI
Description
PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood from the fingertip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This system is intended for self-testing use. FDA UDI

Identifiers

Catalog Number
4770 FDA UDI
Primary DI / UDI-DI
00381934770017 FDA UDI
510(k) Number
K990688 FDA UDI
FDA Product Code
CHH FDA UDI
GMDN Term
Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing

Cholesterol by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing.

Cleared under the same submission

K990688 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 537371bb-c0c7-480d-a944-ec471655a70e 37 fields · synced Jun 6, 2026