HbA1c Blank Solution SK350-BLK

GUDID 00628063401178

SEKISUI DIAGNOSTICS, LLC

Glycated haemoglobin (HbA1c) IVD, calibrator
Primary Device ID00628063401178
NIH Device Record Key4efbaf26-168f-4d9f-a820-e30188d81a86
Commercial Distribution StatusIn Commercial Distribution
Brand NameHbA1c Blank Solution
Version Model NumberSK350-BLK
Catalog NumberSK350-BLK
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count2
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
GS100628063401178 [Primary]
GS110628063401175 [Unit of Use]

FDA Product Code

JITCalibrator, secondary

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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