HbA1c CALIBRATOR SET

GUDID 03661540214806

ELITECH CLINICAL SYSTEMS SAS

Glycated haemoglobin (HbA1c) IVD, calibrator
Primary Device ID03661540214806
NIH Device Record Keyfce13dea-cc32-40f1-bdb6-38e85745adcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHbA1c CALIBRATOR SET
Version Model NumberHBAC-0043
Company DUNS267732378
Company NameELITECH CLINICAL SYSTEMS SAS
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
GS103661540214806 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-09-16
Device Publish Date2016-09-24

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