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pts panels® HDL Cholesterol Controls

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
pts panels® HDL Cholesterol Controls FDA UDI
Generic Name
High density lipoprotein (HDL) cholesterol IVD, control FDA UDI
Device Name
PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements. FDA UDI
Model / Reference
722 FDA UDI
Description
PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements. FDA UDI

Identifiers

Catalog Number
722 FDA UDI
Primary DI / UDI-DI
00381930722010 FDA UDI
510(k) Number
K022401 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
High density lipoprotein (HDL) cholesterol IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: High density lipoprotein (HDL) cholesterol IVD, control

pts panels® HDL Cholesterol Controls by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as High density lipoprotein (HDL) cholesterol IVD, control.

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 28fcfc11-ff68-43cb-96b7-93186cc88f86 37 fields · synced Jun 6, 2026