REDWOOD TOXICOLOGY LABORATORY, INC.

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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, Opiates (DJG) (5) Enzyme Immunoassay, Barbiturate (DIS) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Cannabinoids (LDJ) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Phencyclidine (LCM) (4) Enzyme Immunoassay, Propoxyphene (JXN) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4) Thin Layer Chromatography, Methamphetamine (DJC) (4) Enzyme Immunoassay, Amphetamine (DKZ) (4) Test System, Nicotine, Cotinine, Metabolites (MRS) (1)

Premarket Exempt

No Yes

Clear

reditest® - 10858904006607 Catalog Number : DOA-154-1801

Device Description : PANEL 05 COC150/THC/MOP300/MAMP500/PCP

Device Class :

Duns Number: 929599280

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

reditest® - 10858904006614 Catalog Number : DOA-154-1811

Device Description : PANEL 05 COC150/AMP1000/MAMP500/THC/MOP300

Device Class :

Duns Number: 929599280

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

reditest® - 10858904006621 Catalog Number : DOA-164-1541

Device Description : PANEL 06 COC150/THC/MOP300/OXY100/BZO

Device Class :

Duns Number: 929599280

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

reditest® - 10858904006638 Catalog Number : DOA-164-1551

Device Description : PANEL 06 COC150/AMP1000/MAMP500/THC/MOP300/BZO

Device Class :

Duns Number: 929599280

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

reditest® - 10858904006645 Catalog Number : DUB-114

Device Description : PANEL 1 BUP buprenorphine

Device Class :

Duns Number: 929599280

Premarket Exempt : No

Product Code : DJG

Prescription Use : No

Device Count : 25

reditest® - 10858904006652 Catalog Number : DCT-102

Device Description : DEVICE Cotinine Test Device

Device Class :

Duns Number: 929599280

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : No

Device Count : 25

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