BRANAN MEDICAL CORPORATION

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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, Cannabinoids (LDJ) (5) Enzyme Immunoassay, Opiates (DJG) (4) Thin Layer Chromatography, Methamphetamine (DJC) (2) Enzyme Immunoassay, Amphetamine (DKZ) (2) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (1)

Premarket Exempt

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Fastect II Drug Screen Dipstick Test - 00816555021045 Catalog Number : MF20

Device Description : MTD300 single drug dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021052 Catalog Number : MF21

Device Description : TCA1000 single drug dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : LFH

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021069 Catalog Number : MF22

Device Description : MDMA500 single drug dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021076 Catalog Number : MF23

Device Description : OXY100 single drug dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021083 Catalog Number : MF25

Device Description : BUP10 single drug dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021090 Catalog Number : BF10

Device Description : THC50/COC300 multiple drugs dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DIO, LDJ

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021113 Catalog Number : BF13

Device Description : THC50/MET500 multiple drugs dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJC, LDJ

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021120 Catalog Number : BF16

Device Description : THC50/OPI300 multiple drugs dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG, LDJ

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021137 Catalog Number : BF17

Device Description : THC50/MDMA500 multiple drugs dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : LDJ, DKZ

Prescription Use : Yes

Device Count : 1

Fastect II Drug Screen Dipstick Test - 00816555021144 Catalog Number : TF12

Device Description : THC50/OPI300/MET500 multiple drugs dipstick test

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJC, DJG, LDJ

Prescription Use : Yes

Device Count : 1

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