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, Opiates (DJG) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (3) Enzyme Immunoassay, Amphetamine (DKZ) (2) Thin Layer Chromatography, Methamphetamine (DJC) (2) Glucose Oxidase, Glucose (CGA) (1) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1) Test, Follicle Stimulating Hormone (Fsh), Over The Counter (NGA) (1) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

No Yes

Clear

QuikStrip Multidrug Screening Dip Card Test - 00748349000373 Catalog Number :

Device Description : QuikStrip Multidrug 5 Test, AMP 500, COC 300, MET 500, OP I 2000, THC 50

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Syntron QuikStrip - 00748349000397 Catalog Number :

Device Description : Syntron QuikStrip Pregnancy Test

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

QuikScreen - 00748349000403 Catalog Number :

Device Description : QUIKSCREEN Multi 5 Drug Cup Test – BUP 10, BZD 300, COC 300, OPI 2000, THC 50

Device Class : 2

Duns Number: 174517060

Premarket Exempt : No

Product Code : LDJ, DIO, DJG

Prescription Use : No

Device Count : 1

Be Sure - 00748349000700 Catalog Number :

Device Description : Menopause Test - 1 Test

Device Class : 1

Duns Number: 174517060

Premarket Exempt : Yes

Product Code : NGA

Prescription Use : No

Device Count : 1

Glucose Pilot - 00748349000717 Catalog Number : 10001

Device Description : Glucose Pilot - The Complete Glucose Monitoring System

Device Class : 1

Duns Number: 174517060

Premarket Exempt : No

Product Code : NBW, CGA, JJX

Prescription Use : No

Device Count : 1

QuikScreen 7+4 - 00748349000724 Catalog Number :

Device Description : QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + P QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/NBP Cat. 65732-7

Device Class :

Duns Number: 174517060

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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