BRANAN MEDICAL CORPORATION

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Filters

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) (5) Enzyme Immunoassay, Cannabinoids (LDJ) (5) Enzyme Immunoassay, Amphetamine (DKZ) (4) Thin Layer Chromatography, Methamphetamine (DJC) (3) Enzyme Immunoassay, Opiates (DJG) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. (DOE) (1) Enzyme Immunoassay, Barbiturate (DIS) (1) Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (MLK) (1)

Premarket Exempt

Clear

Monitect Drug Screen Cassette Test - 00816555020109 Catalog Number : MC21

Device Description : TCA1000 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : MLK

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020116 Catalog Number : MC22

Device Description : MDMA500 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020123 Catalog Number : MC23

Device Description : OXY100 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020130 Catalog Number : BC10

Device Description : THC50/COC300 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DIO, LDJ

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020154 Catalog Number : BC17S

Device Description : BAR300/BZO300 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : JXM, DIS

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020161 Catalog Number : BC28

Device Description : AMP1000/MET500 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJC, DKZ

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020178 Catalog Number : TC11

Device Description : MET500/THC50/COC300 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DIO, LDJ, DJC

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020185 Catalog Number : TC13

Device Description : OPI300/THC50/COC300 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DIO, LDJ, DOE

Prescription Use : Yes

Device Count : 1

Monitect Drug Screen Cassette Test - 00816555020192 Catalog Number : TC19

Device Description : AMP1000/THC50/COC300 Cassette Tests

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DIO, LDJ, DKZ

Prescription Use : Yes

Device Count : 1

Oratect Oral Fluid Collection Tube - 00816555020208 Catalog Number : CM-190

Device Description : Oral Fluid Specimen Collection Tube

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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