N-geneous LDL-ST Cholesterol Calibrator 80-5666-02

GUDID 00628063400744

SEKISUI DIAGNOSTICS, LLC

Low density lipoprotein (LDL) cholesterol IVD, calibrator
Primary Device ID00628063400744
NIH Device Record Keya8410a49-798d-4838-8bcc-eef41052185c
Commercial Distribution StatusIn Commercial Distribution
Brand NameN-geneous LDL-ST Cholesterol Calibrator
Version Model Number80-5666-02
Catalog Number80-5666-02
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count3
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
GS100628063400744 [Primary]
GS110628063400741 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JISCALIBRATOR, PRIMARY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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