Direct A1c Control Kit 55136

GUDID 03661540304286

A material which is used to verify the performance of Direct A1c Reagent Kit 55370.

ELITECHGROUP INC.

Glycated haemoglobin (HbA1c) IVD, control
Primary Device ID03661540304286
NIH Device Record Key8a1e3ec9-3faa-4f36-9018-a93bade35bc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect A1c Control Kit
Version Model Number55136
Catalog Number55136
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

Customer Support Contacts

Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com
Phone(800) 453 2725
Emailservice.ebs@elitechgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540304286 [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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