Address:No.136 Mashan Meiliang Road,Binhu,Wuxi Jiangsu,CN
Device Description : A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemo A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determin A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit.lnten Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit.lntended use: This A1C EZ2.0 Glyconemogoin Test Kit is intended to be used with the A1CEZ 2.0Glyconemogloin Arnalyzer to quaniativly measue hemoglobinA1c(HbA1c) level in whole blood (capilary blood).This test ki i for self-testinguse, as an aid to monitor the effectiveness of diabetes control.Contents: Code Chip x 1 piece; HbA1c Test Strip x 25 pieces; Sampler x 25 pieces;Buffer Ax 1 bottle;Bulffer Bx 1 bottle.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit.Inten Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit.Intended use: This GluCoA1c glycohemoglobin test kit is intended to be used with the GluCoA1c blood glucose and glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c) level in whole blood (capillary blood or venous blood). Contents: Code Chip x 1 piece; HbA1c Test Strip x 12 pieces; Sampler x 12 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c bl GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blood glucose test strips are for use with the GluCoA1c analyzer to quantitatively measure the glucose level of fresh capillary whole blood. Contents: 50 test strips; package insert.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tes A1cChek Pro Glycohemoglobin Test Kit (Boronate Affinity Chromatography), 100 Tests/Kit. Intended use: This A1cChek Pro Glycohemoglobin Test Kit is intended to be used with the A1cChek Pro Glycohemoglobin Analyzer to quantitatively measure hemoglobin A1c(HbA1c) level in whole blood (capillary blood or venous blood).This test kit is for professional use. Contents: Code Chip x 1 piece; HbA1c Test Strip x 100 pieces; Sampler x 100 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle; Blood Collector x 100 pieces.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit .Inte Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit .Intended use: This GluCoA1c glycohemoglobin test kit is intended to be used with the GluCoA1c blood glucose and glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c) level in whole blood (capillary blood or venous blood). Contents: Code Chip x 1 piece; HbA1c Test Strip x 12 pieces; Sampler x 12 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglo Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (glycohemoglobin analyzers and test kits) with the methodology of boronate affinity chromatography, manufactured by Wuxi BioHermes Bio & Medical Technology Co.,Ltd.. Contents: Level 1: 5 vials x 50uL; Level 2: 5 vials x 50uL; Package Insert×1.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Test/Kitlntended use: this combo test kit is used for in vitro diagnostic testing for qualitatively measuring the Insulin-like Growth Factor Binding Proteir-1 (IGFBP-1) and fetal Fibronectin (fFN) levels in the secretions of pregnant women patients. It can work as an auxiliary diagnosis of membrane rupture in pregnant women (including premature rupture of membranes) and also work as a method to predict the pregnancy status in labor (including premature delivery).Contents: 1.one dipstick in a sealed alurminum foil pouch with desiccant; 2.one tube of specimen extraction solution (1.0 ml), this phosphate-bufferedsolution contains preservatives; 3.one instruction for use.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No
Device Description : A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemo A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip.
Device Class :
Duns Number: 528192913
Premarket Exempt : No
Prescription Use : No