N-geneous LDL-ST Cholesterol Reagent (R2) 80-5729-02

GUDID 00628063400768

SEKISUI DIAGNOSTICS, LLC

Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400768
NIH Device Record Key88891921-21b0-452e-9aad-2f6af057a34e
Commercial Distribution StatusIn Commercial Distribution
Brand NameN-geneous LDL-ST Cholesterol Reagent (R2)
Version Model Number80-5729-02
Catalog Number80-5729-02
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
GS100628063400768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRRSYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

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

On-Brand Devices [N-geneous LDL-ST Cholesterol Reagent (R2)]

0062806340076880-5729-02
0062806340073780-5714-00

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