POLYMER TECHNOLOGY SYSTEMS, INC.

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

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- Catalog Number : 2134

Device Description : The tubes are a combination of a short glass capillary pipette that is physicall The tubes are a combination of a short glass capillary pipette that is physically combined with a plastic pipette that is capable of dispensing a given volume of blood from the capillary tube to a test strip. The glass capillary draws blood from a finger stick site using capillary force. Two small vents in the plastic bulb allow for capillary action. After drawing up of the blood into the glass tube, the two small vents in the plastic tube are then covered with two fingers and the bulb is squeezed to dispense the blood. The PTS Collect capillary tubes are single-use, disposable devices.

Device Class :

Duns Number: 835772872

Premarket Exempt : Yes

Product Code : GIO

Prescription Use : Yes

Device Count : 25

- Catalog Number : 2400

Device Description : PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides 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 : NGO, LBR, JGY, NBW, NAQ, CGA

Prescription Use : Yes

Device Count : 15

- Catalog Number : 2412

Device Description : PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to mon PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL 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 : CGA, NBW, LBR, CHH

Prescription Use : Yes

Device Count : 15

- Catalog Number : 2469

Device Description : PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to mon PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL 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, LBR, NBW, CGA

Prescription Use : Yes

Device Count : 10

- Catalog Number : 2470

Device Description : PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to moni PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to monitor total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA or Plus analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : JGY, CHH, LBR

Prescription Use : Yes

Device Count : 10

- Catalog Number : 2471

Device Description : PTS Panels eGLU™ glucose test strips are in vitro diagnostic devices used to mon PTS Panels eGLU™ glucose test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : Yes

Device Count : 12

- Catalog Number : 2477

Device Description : PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to mon PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL 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, CGA, NBW, LBR

Prescription Use : Yes

Device Count : 10

- Catalog Number : 2478

Device Description : CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic d CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ are in vitro diagnostic devices used to monitor glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus analyzer.

Device Class :

Duns Number: 835772872

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 10

- Catalog Number : 2700

Device Description : The CardioChek® Plus professional analyzer is intended for in vitro diagnostic u The CardioChek® Plus 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 : LBR, CHH, CGA, NBW, JGY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 2701

Device Description : The CardioChek® Plus professional analyzer is intended for in vitro diagnostic u The CardioChek® Plus 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 : NBW, LBR, JGY, CHH, CGA

Prescription Use : Yes

Device Count : 1