Healgen (Private Label) EtG Urine Dip *300ng

GUDID 00895330002752

EtG Urine Dip *300ng

CONFIRM BIOSCIENCES, INC.

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Primary Device ID00895330002752
NIH Device Record Key11035316-3581-4538-8f7d-c0c1476b5a60
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealgen (Private Label) EtG Urine Dip *300ng
Version Model NumberCB-HE-ETG 300
Company DUNS806524968
Company NameCONFIRM BIOSCIENCES, INC.
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
GS100895330002752 [Primary]

FDA Product Code

DMJTest Reagents For Ethyl Alcohol

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-05-24
Device Publish Date2016-09-06

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