MAGNESIUM Reagent 175-12

GUDID 00628063400799

SEKISUI DIAGNOSTICS, LLC

Magnesium (Mg2+) IVD, kit, spectrophotometry
Primary Device ID00628063400799
NIH Device Record Keyf7618459-938d-4c94-b8db-b4a5832c29d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAGNESIUM Reagent
Version Model Number175-12
Catalog Number175-12
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count4
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
GS100628063400799 [Primary]
GS110628063400796 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JGJPHOTOMETRIC METHOD, MAGNESIUM

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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