HbA1c CONTROL L+ H

GUDID 03701700828907

VITALSCIENTIFIC

Glycated haemoglobin (HbA1c) IVD, control
Primary Device ID03701700828907
NIH Device Record Key859583fb-8af1-4a14-8721-a3205528d97a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHbA1c CONTROL L+ H
Version Model NumberHBAC-0049
Company DUNS267732378
Company NameVITALSCIENTIFIC
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701700828907 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

On-Brand Devices [HbA1c CONTROL L+ H]

03701700828907HBAC-0049
03701700821205HBAC-0049

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