DriDye 405 E002-405

GUDID 00850229007195

Analyzer Quality Control

AWARENESS TECHNOLOGY, INCORPORATED

Optical instrument calibration/verification solution IVD
Primary Device ID00850229007195
NIH Device Record Keycf0a0beb-dcfb-4b57-b57b-302bfc614728
Commercial Distribution StatusIn Commercial Distribution
Brand NameDriDye 405
Version Model Number405
Catalog NumberE002-405
Company DUNS071065130
Company NameAWARENESS TECHNOLOGY, INCORPORATED
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 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
GS100850229007195 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2016-06-30

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00850229007102 - StatFax2023-06-13
00850229007126 - LumiStat2023-06-13

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