Address:510 Oakmead Pkwy,SUNNYVALE,CA,94085,US
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
Device Description : The A1CNow® Self Check Test System provides quantitative measurement of the perc The A1CNow® Self Check 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 : No
Device Description : Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and ot Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and other nicotine-containing products. Cotinine has a longer half-life than nicotine, which allows for a more accurate assessment of smoking or exposure status and better monitoring of progress in smoking cessation programs.1 Because of its longer half-life and relative ease of detection, cotinine is the choice metabolite to assess exposure to nicotine. The amount of cotinine present in the blood is proportional to the amount and recency of nicotine exposure. The PTS Detect cotinine system provides measurement of cotinine in capillary (fingerstick) or venous whole blood.
Device Class :
Duns Number: 835772872
Premarket Exempt : Yes
Prescription Use : No
Device Description : The A1CNow® Self Check Test System provides quantitative measurement of the perc The A1CNow® Self Check 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 : No
Device Description : The PTS Connect™ Universal Solution offers the ability to connect wired and wire The PTS Connect™ Universal Solution offers the ability to connect wired and wireless PTS Diagnostics analyzers to the PTS Connect Universal Solution. The PTS Connect Universal Solution will collect test results from the connected devices, generate patient results, and allow the user to export data.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : No
Device Description : CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitr CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnostic devices used to measure glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : No
Device Description : CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : No
Device Description : The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devic The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
Device Class : 2
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : No
Device Description : The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : No