Address:510 Oakmead Pkwy,SUNNYVALE,CA,94085,US
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
Prescription Use : Yes
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
Prescription Use : Yes
Device Description : PTS Panels eGLU™ test strips are in vitro diagnostic devices used to monitor glu PTS Panels eGLU™ 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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
Device Description : The A1CNow®+ Multi-Use Test System provides quantitative measurement of the perc The A1CNow®+ Multi-Use Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Device Class :
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes