Healgen (Private Label) - 253

GUDID 00856464008584

Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25

CONFIRM BIOSCIENCES, INC.

Cocaine/cocaine metabolite IVD, reagent
Primary Device ID00856464008584
NIH Device Record Key771bc9b8-14a5-45b1-9b89-75be93439b26
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealgen (Private Label) - 253
Version Model NumberCB-HE-CUP-253
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 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
GS100856464008584 [Primary]

FDA Product Code

NFTTest, Amphetamine, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-07
Device Publish Date2024-09-27

Devices Manufactured by CONFIRM BIOSCIENCES, INC.

00856464008584 - Healgen (Private Label) - 2532024-10-07Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25
00856464008584 - Healgen (Private Label) - 2532024-10-07 Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25
00856464008416 - DrugConfirm2022-11-02 1 Drug Tested Home Drug Test (THC)
10856464008505 - DrugConfirm2022-11-02 1 Drug Tested Home Drug Test (THC) 2 Pack
00856464008409 - DrugConfirm2022-11-01 4 Drugs Tested Home Drug Test
00856464008423 - DrugConfirm2022-11-01 7 Drugs Tested Home Drug Test
00856464008430 - DrugConfirm2022-11-01 14 Drugs Tested Home Drug Test
00856464008447 - DrugConfirm2022-11-01 1 Drug Tested Home Drug Test (COC)
00895330002073 - DrugConfirm Advanced™ 6 Panel Instant Drug Test2021-05-24 This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetamines (mAMP), Amphetamines (AMP), Phencyclidine (P

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