Cholesterol 4770

GUDID 10381934770014

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.

POLYMER TECHNOLOGY SYSTEMS, INC.

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

• Primary Device ID: 10381934770014
• NIH Device Record Key: 537371bb-c0c7-480d-a944-ec471655a70e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cholesterol
• Version Model Number: REF 4770
• Catalog Number: 4770
• Company DUNS: 835772872
• Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com
• Phone: +1(877)870-5610
• Email: customerservice@ptsdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381934770017 [Primary]
GS1	10381934770014 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990688

FDA Product Code

• CHH: ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.

• 10381934770014 - Cholesterol: 2025-06-24PTS 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.
• 10381934770014 - Cholesterol: 2025-06-24 PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood fro
• 10381934774012 - PTS Diagnostics Capillary Tubes: 2025-06-24 PTS Collect Capillary Tubes are intended to obtain a drop of whole blood from a fingerstick for self-testing. Capillary tubes ar
• 10381933080015 - A1CNow Self Check, 8ct.: 2023-11-02 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
• 10021292015029 - TRUE+ A1CNow Self Check: 2023-08-07 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
• 10381932488010 - Assy Vial, eGLU, 13 ct.: 2023-08-07 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who
• 10381934753017 - Lipid Panel, 15ct., CCPlus Home: 2023-06-28 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL
• 10381934755011 - eGLU, 15ct., CCPlus Home: 2023-06-28 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who
• 10381934752010 - Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk): 2023-06-09 CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholest