Healgen (Private Label) FLATCUP-8104A3

GUDID 00895330002745

10 Panel Flat-Cup w/ADU COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP+A3

CONFIRM BIOSCIENCES, INC.

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Primary Device ID00895330002745
NIH Device Record Key3d7c5942-da04-40e6-a805-58adfe5ff9e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealgen (Private Label) FLATCUP-8104A3
Version Model NumberCB-HE-FLATCUP-8104A3
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
GS100895330002745 [Primary]

FDA Product Code

LAFGas Chromatography, Methamphetamine

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 Date2016-09-07

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