POLYMER TECHNOLOGY SYSTEMS, INC.

Address:510 Oakmead Pkwy,SUNNYVALE,CA,94085,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL (CHH) (5) COLORIMETRIC METHOD, TRIGLYCERIDES (JGY) (4) LDL & VLDL PRECIPITATION, HDL (LBR) (4) LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER (NAQ) (3) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (3) TEST, TRIGLYCERIDES, OVER THE COUNTER (NGO) (2) LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES (CDT) (2) ENZYMATIC METHOD, CREATININE (JFY) (1) ACID, ALPHA-KETOBUTYRIC AND NADH (U.V.), HYDROXYBUTYRIC DEHYDROGENASE (JMK) (1)

Premarket Exempt

No Yes

Clear

PTS Panels® Triglycerides Test Strips - 00381931716018 Catalog Number : 1716

Device Description : PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to mo 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.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CDT, JGY

Prescription Use : Yes

Device Count : 25

PTS Panels® Ketones Test Strips - 00381931718012 Catalog Number : 1718

Device Description : PTS Panels® Ketone Test Strips are in vitro diagnostic devices used to monitor k PTS Panels® Ketone Test Strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek or CardioChek PA analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : JMK

Prescription Use : Yes

Device Count : 25

PTS Panels® Creatinine Test Strips - 00381931720015 Catalog Number : 1720

Device Description : PTS Panels® Creatinine Test Strips are in vitro diagnostic devices used to monit PTS Panels® Creatinine Test Strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek PA analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : JFY

Prescription Use : Yes

Device Count : 25

CardioChek® PA Professional Analyzer, Refurbished - 00381931757011 Catalog Number : 1757

Device Description : The CardioChek® PA professional analyzer is intended for in vitro diagnostic use The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : JGY, NBW, CHH, LBR, NGO, NAQ, CGA

Prescription Use : Yes

Device Count : 1

PTS Panels® Chol+Glu Test Strips - 00381931765016 Catalog Number : 1765

Device Description : PTS Panels CHOL+GLU test strips are in vitro diagnostic devices used to monitor 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 Plus or CardioChek PA analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CHH, NBW, CGA

Prescription Use : Yes

Device Count : 25

CardioChek® Analyzer; Refurbished - 00381931782013 Catalog Number : 1782

Device Description : The CardioChek® analyzer is intended for in vitro diagnostic use to test whole b The CardioChek® analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.

Device Class : 1

Duns Number: 835772872

Premarket Exempt : No

Product Code : CHH, JGY, CGA, NBW, NGO, LBR, NAQ

Prescription Use : Yes

Device Count : 1

PTS Panels® HDL Cholesterol Test Strips - 00381931788015 Catalog Number : 1788

Device Description : PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : LBR, NAQ

Prescription Use : No

Device Count : 3

PTS Panels® Triglycerides Test Strips - 00381931789012 Catalog Number : 1789

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : JGY, CDT

Prescription Use : No

Device Count : 3

PTS Panels® Cholesterol Test Strips - 00381931790018 Catalog Number : 1790

Device Description : PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to moni PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 3

PTS Panels® CHOL+HDL Test Strips - 00381931821019 Catalog Number : 1821

Device Description : PTS Panels CHOL+HDL test strips are in vitro diagnostic devices used to monitor PTS Panels CHOL+HDL test strips are in vitro diagnostic devices used to monitor HDL cholesterol and total cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : LBR, CHH

Prescription Use : Yes

Device Count : 25

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