SALICYLATE-SL Assay 511-40

GUDID 00628063400867

SEKISUI DIAGNOSTICS, LLC

Salicylate IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400867
NIH Device Record Key099ca993-5e62-4375-b9ae-b786933b48d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALICYLATE-SL Assay
Version Model Number511-40
Catalog Number511-40
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
GS100628063400867 [Primary]

FDA Product Code

DKJCOLORIMETRY, SALICYLATE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-05
Device Publish Date2016-09-16

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