Direct A1c Calibrator Kit 55120

GUDID 03661540304293

Calibrator intended to establish known points of reference for use with Direct A1c Reagent Kit 55370.

ELITECHGROUP INC.

Glycated haemoglobin (HbA1c) IVD, calibrator
Primary Device ID03661540304293
NIH Device Record Keya29ecf75-0698-43aa-8577-3c2a36d383df
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect A1c Calibrator Kit
Version Model Number55120
Catalog Number55120
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540304293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-09
Device Publish Date2023-10-01

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