Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Address:No.136 Mashan Meiliang Road,Binhu,Wuxi Jiangsu,CN

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- Catalog Number : A1C-M41

Device Description : A1cChek Express Glycohemoglobin analyzer is for use with the A1cChek Express Gly A1cChek Express Glycohemoglobin analyzer is for use with the A1cChek Express Glycohemoglobin Test Kit to quantitatively measure the HbA1c in human capillary blood or venous blood.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : A1C-S42

Device Description : A1cChek Express Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 25 A1cChek Express Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 25 Tests/Kit .Intended use: This A1cChek Express glycohemoglobin test kit is intended to be used with the A1cChek Express glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c)level in whole blood (capillary blood or venous blood). Contents: HbA1c Test Strip x 25; Sampler x 25; Buffer Kit x 1; Rinse Card x 1; Code Chip x 1; lnsert x 1.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : GLU-S32

Device Description : GluCoA1c Blood Glucose Test Strips, 50 Tests/Kit. Intended use: The GluCoA1c blo 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

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : A1C-C12

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

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : GCA-M31

Device Description : GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analy GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : GCA-M41

Device Description : GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analy GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : GCA-M31

Device Description : GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analy GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : GCA-M41

Device Description : GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analy GluCoA1c Blood Glucose and Glycohemoglobin Analyzer.Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Test Kit and GluCoA1c Blood Glucose Test Strips to quantitatively measure the HbA1c in human capillary blood or venous blood,and the blood glucose in human capillary blood.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : HP-M51

Device Description : The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC).

Device Class : 2

Duns Number: 528192913

Premarket Exempt : No

Product Code : PDJ

Prescription Use : No

Device Count : 1

- Catalog Number : HP-Z111

Device Description : Glycohemoglobin Analytical Column 1 pcs/kit (500 tests)The Glycohemoglobin Ana Glycohemoglobin Analytical Column 1 pcs/kit (500 tests)The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood.

Device Class :

Duns Number: 528192913

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1