BioHermes A1cChek Pro Glycohemoglobin Test Kit A1C-S32

GUDID 06935784400064

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.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Primary Device ID06935784400064
NIH Device Record Key4d3ff21c-13f1-4571-80e5-a4af14598c8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioHermes A1cChek Pro Glycohemoglobin Test Kit
Version Model NumberA1C-PRO S01
Catalog NumberA1C-S32
Company DUNS528192913
Company NameWuxi Biohermes Bio & Medical Technology Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106935784400064 [Primary]
GS116935784400061 [Package]
Package: box [2 Units]
In Commercial Distribution
GS126935784400068 [Package]
Contains: 16935784400061
Package: box [5 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-02
Device Publish Date2021-05-25

Devices Manufactured by Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

06935784400088 - BioHermes Glycohemoglobin Quality Control2022-09-05 Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as a
16935784410008 - BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer 2022-09-05 A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the ris
16935784420250 - BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer2022-09-05 GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Te
16935784420267 - BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer2022-09-05 GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Te
06935784400286 - BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit2022-01-12 Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Test/Kit lntended use: this combo test
06935784430016 - BioHermes Automated Glycohemoglobin Analyzer2022-01-12 The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in
06935784400019 - BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer 2021-06-02 A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the ris
06935784400026 - BioHermes A1cChek Pro Glycohemoglobin Analyzer2021-06-02 A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood usi

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.