BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer GCA-M31

GUDID 06935784420239

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.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care
Primary Device ID06935784420239
NIH Device Record Key0822dc36-a02b-48a5-8a95-b0ea52f13b87
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
Version Model NumberGLU-A1C M12
Catalog NumberGCA-M31
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
GS106935784420239 [Primary]
GS116935784420236 [Package]
Package: box [18 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 GluCoA1c Blood Glucose and Glycohemoglobin Analyzer]

06935784420246GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use
06935784420239GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use
16935784420267GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use
16935784420250GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use

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