COASTLINE MEDICAL MANAGEMENT, LLC

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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, Amphetamine (DKZ) (1) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Opiates (DJG) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

Clear

Coastline Explorer Cup - 00868754000208 Catalog Number : X13-DT13A

Device Description : THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA5 THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr,Ni,pH,Bl,S.G. drugs of abuse test cup

Device Class : 2

Duns Number: 079629844

Premarket Exempt : No

Product Code : LFG, DJR, DIS, JXM, DKZ, DJC, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

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