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, Opiates (DJG) (6) Thin Layer Chromatography, Methamphetamine (DJC) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Phencyclidine (LCM) (4) Test, Opiates, Over The Counter (NGL) (4) Test, Amphetamine, Over The Counter (NFT) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (4) Test, Benzodiazepine, Over The Counter (NFV) (4) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (4) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (3) Test, Methamphetamine, Over The Counter (NGG) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Test, Cannabinoid, Over The Counter (NFW) (2) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

Clear

AmediCheck Instant Test Cup - 00816555021472 Catalog Number : C-60B02

Device Description : THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : LDJ, DJG, LFG, DJR, NFV, DIS, DKZ, LCM, NGG, NFT, NGL, NFY, NFW, DIO, DJC, JXM

Prescription Use : Yes

Device Count : 1

Instant Test Cup - 00816555021489 Catalog Number : 10-100

Device Description : THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 drugs of abuse test cup (CLIA WAIVED)

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG, LFG, DJR, NFV, DIS, DJC, LCM, NGG, NFT, NGL, NFY, NFW

Prescription Use : No

Device Count : 1

Instant Test Cup - 00816555021496 Catalog Number : 10-200

Device Description : COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA100 COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG, LFG, DJR, NFV, DIS, DJC, LCM, NGG, NFT, NGL, NFY

Prescription Use : No

Device Count : 1

Instant Test Cup - 00816555021502 Catalog Number : 10-300

Device Description : COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with adulteration OX/SG/pH drug COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

Product Code : DJG, NFV, DIS, NFT, NGL, NFY

Prescription Use : No

Device Count : 1

ToxCup Drug Screen Cup - 00816555021519 Catalog Number : PT13

Device Description : AMP1000/COC300/MET500/OPI2000/THC50

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ToxCup Drug Screen Cup - 00816555021526 Catalog Number : DT14A

Device Description : THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA5 THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300A w/ Adulteration screen tests Cr, Ni, pH, Bl, S.G.

Device Class : 2

Duns Number: 184347305

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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