SYNTRON BIORESEARCH, INC.

Address:2774 LOKER AVE. WEST,CARLSBAD,CA,92010,US

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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, Cocaine And Cocaine Metabolites (DIO) (9) Enzyme Immunoassay, Opiates (DJG) (9) Enzyme Immunoassay, Amphetamine (DKZ) (9) Enzyme Immunoassay, Methadone (DJR) (8) Enzyme Immunoassay, Cannabinoids (LDJ) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Thin Layer Chromatography, Methamphetamine (DJC) (6) Enzyme Immunoassay, Barbiturate (DIS) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (3)

Premarket Exempt

No Yes

Clear

QuikScreen - 00748349000113 Catalog Number :

Device Description : QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : LFH, DJG, DIO, JXM, DKZ

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000137 Catalog Number :

Device Description : QuikScreen Multi 7 Drug Cup Test - AMP 500, MDMA 500, COC 300, MET 500, OPI 300 QuikScreen Multi 7 Drug Cup Test - AMP 500, MDMA 500, COC 300, MET 500, OPI 300, MAD 300, THC 50

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : DJG, DJR, DJC, DIO, LDJ, DKZ

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000144 Catalog Number :

Device Description : QuikScreen Multi 8+5 Drug Cup Test - AMP 500, BUP 10, COC 300, MAD 300, MDMA 50 QuikScreen Multi 8+5 Drug Cup Test - AMP 500, BUP 10, COC 300, MAD 300, MDMA 500, MET 500, OPI 300, THC 50, + pH/SG/NBP/GTA/CRE

Device Class :

Duns Number: 174517060

Premarket Exempt : No

Product Code : DJG, DJR, DIO, DJC, LDJ, DKZ

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000151 Catalog Number :

Device Description : QuikScreen Multi 12+3 Drug Cup Test - AMP 1000, BAR 300, BUP 10, BZD 300, COC 30 QuikScreen Multi 12+3 Drug Cup Test - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 300, OXY 100, PCP 25, THC 50 + pH/NBP/SG

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000168 Catalog Number :

Device Description : QuikScreen Multi 8 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, QuikScreen Multi 8 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, OPI 300, OXY 100, THC 50

Device Class :

Duns Number: 174517060

Premarket Exempt : No

Product Code : DJG, DJR, DIO, LDJ, JXM, DKZ

Prescription Use : No

Device Count : 1

QuikScreen Multi 12 Drug Cup Test - 00748349000175 Catalog Number :

Device Description : QUIKSCREEN Multi 12 Drug Cup Test:AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, O QUIKSCREEN Multi 12 Drug Cup Test:AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

QuikStrip MultiDrug X Screening Dip Card - 00748349000182 Catalog Number :

Device Description : QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : DJR

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000199 Catalog Number :

Device Description : QUIKSCREEN MULTI 11 DRUG CUP TEST - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300 QUIKSCREEN MULTI 11 DRUG CUP TEST - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 300, OXY 100, PCP 25, TCA 1000

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : LFH, DJG, LCM, DJR, DJC, DIO, JXM, DIS, DKZ

Prescription Use : No

Device Count : 1

QuikScreen 4 Drug Cup - 00748349000205 Catalog Number :

Device Description : QuikScreen 4 Drug Cup - AMP 1000, COC 300, OPI 2000,THC 50

Device Class :

Duns Number: 174517060

Premarket Exempt : No

Product Code : DJG, LDJ, DIO, DKZ

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000229 Catalog Number :

Device Description : QuikScreen Multi 9+1 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300 QuikScreen Multi 9+1 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, MET 1000, OPI 300, OPI 2000, OXY 100 + ALC

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : DJG, DJR, DJC, DIO, JXM, DKZ

Prescription Use : No

Device Count : 1

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