BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer A1C-M21

GUDID 06935784400019

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.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care
Primary Device ID06935784400019
NIH Device Record Keybe0845eb-8729-43a2-a5a6-5b10951ce3b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
Version Model NumberA1C EZ 2.0
Catalog NumberA1C-M21
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 Usefalse
Lot Batchtrue
Serial Numbertrue
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
GS106935784400019 [Primary]
GS116935784400016 [Package]
Package: box [24 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

On-Brand Devices [BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer ]

06935784400019A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentra
16935784410008A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentra
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