DRI Salicylate Serum Tox Assay

GUDID 00884883001145

Microgenics Corporation

Salicylate IVD, kit, enzyme spectrophotometry
Primary Device ID00884883001145
NIH Device Record Keyb823e0a9-0bd4-4542-bd3b-55b54be3a9d6
Commercial Distribution Discontinuation2016-09-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDRI Salicylate Serum Tox Assay
Version Model Number0977
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883001145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKJColorimetry, Salicylate

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 Date2016-09-12

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