PHAMATECH, INCORPORATED

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Kit, Test, Multiple, Drugs Of Abuse, Over The Counter (MVO) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1)

Premarket Exempt

Clear

At Home Drug Test for Methamphetamine - 00674033090682 Catalog Number :

Device Description : Urine based drug testing device for Methamphetamine

Device Class : U

Duns Number: 947803078

Premarket Exempt : No

Product Code : MVO

Prescription Use : No

Device Count : 1

At Home Single Panel COC + Timer - 00674033090736 Catalog Number :

Device Description : Single Panel Cocaine urine drug test device with Timer

Device Class : 2

Duns Number: 947803078

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 1

At Home Drug Test for Marijuana - 00674033090781 Catalog Number :

Device Description : Urine based drug of abuse test for THC

Device Class : U

Duns Number: 947803078

Premarket Exempt : No

Product Code : MVO

Prescription Use : No

Device Count : 1

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