HbA1c Assay SK350-60

GUDID 00628063401147

SEKISUI DIAGNOSTICS, LLC

Glycated haemoglobin (HbA1c) IVD, reagent
Primary Device ID00628063401147
NIH Device Record Key9ef037f8-f0e6-44fc-86fc-846c79e4cc03
Commercial Distribution StatusIn Commercial Distribution
Brand NameHbA1c Assay
Version Model NumberSK350-60
Catalog NumberSK350-60
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
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
GS100628063401147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDJHemoglobin A1c test system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

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