JANT PHARMACAL CORPORATION

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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

Enzyme Immunoassay, Opiates (DJG) (2) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. (DOE) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1) Enzyme Immunoassay, Amphetamine (DKZ) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

Yes No

Clear

accutest® - 10763924220424 Catalog Number :

Device Description : ACCUTEST Buprenorphine drug screen test card - 10 ng/mL

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924309914 Catalog Number :

Device Description : Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : LFG

Prescription Use : No

Device Count : 25

Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924310910 Catalog Number :

Device Description : Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924311917 Catalog Number :

Device Description : Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DKZ

Prescription Use : No

Device Count : 25

Accutest CLEAR Barbiturates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924312914 Catalog Number :

Device Description : Accutest CLEAR Barbiturates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DIS

Prescription Use : No

Device Count : 25

Accutest CLEAR Cocaine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924314918 Catalog Number :

Device Description : Accutest CLEAR Cocaine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DIO

Prescription Use : No

Device Count : 25

Accutest CLEAR Methamphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/K - 10763924315915 Catalog Number :

Device Description : Accutest CLEAR Methamphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DJC

Prescription Use : No

Device Count : 25

Accutest CLEAR Methadone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924316912 Catalog Number :

Device Description : Accutest CLEAR Methadone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DJR

Prescription Use : No

Device Count : 25

Accutest CLEAR Opiates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924317919 Catalog Number :

Device Description : Accutest CLEAR Opiates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : DOE

Prescription Use : No

Device Count : 25

Accutest CLEAR PCP Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit - 10763924318916 Catalog Number :

Device Description : Accutest CLEAR PCP Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Device Class :

Duns Number: 797393659

Premarket Exempt : No

Product Code : LCM

Prescription Use : No

Device Count : 25

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