TRANSMED CO, LLC

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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) (7) Enzyme Immunoassay, Amphetamine (DKZ) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (7) Enzyme Immunoassay, Opiates (DJG) (6) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (6) Gas Chromatography, Methamphetamine (LAF) (6) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Phencyclidine (LCM) (3) Enzyme Immunoassay, Barbiturate (DIS) (3) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1) Enzyme Immunoassay, Propoxyphene (JXN) (1) Indicator, Cellulose Fluorescent, Tlc (DJO) (1)

Premarket Exempt

Clear

CSI - 00850798007008 Catalog Number :

Device Description : CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, CLICK SEAL CAP, AMP, BAR, BU CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, CLICK SEAL CAP, AMP, BAR, BUP, BZO, COC, MET, MDMA, OPI, MTD, OXY, PCP, PPX, TCA, THC, 25/BX

Device Class : 2

Duns Number: 022637761

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CSI - 00850798007039 Catalog Number :

Device Description : CSI Cup - CLIA Screen In-Vitro 14 Panel + 3 AD Drug Test, CLICK SEAL CAP, AMP, B CSI Cup - CLIA Screen In-Vitro 14 Panel + 3 AD Drug Test, CLICK SEAL CAP, AMP, BAR, BUP, BZO, COC, MET, MDMA, OPI, MTD, OXY, PCP, PPX, TCA, THC, + OX, PH, SG,

Device Class :

Duns Number: 022637761

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CSI - 00850798007602 Catalog Number :

Device Description : CSI Cup - CLIA Screen In-Vitro 8 Panel, CLIA Waived, AMP, BUP, BZO, COC, MOP, M CSI Cup - CLIA Screen In-Vitro 8 Panel, CLIA Waived, AMP, BUP, BZO, COC, MOP, MTD, OXY, THC, 25/BX

Device Class : 2

Duns Number: 022637761

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CSI - 00850798007633 Catalog Number :

Device Description : CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC, MET, MOP, THC, 25/BX

Device Class :

Duns Number: 022637761

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CSI - 00850798007664 Catalog Number :

Device Description : CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZ CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZO, COC, MET, MDMA, MOP, MTD, OXY, THC, 25/BX

Device Class : 2

Duns Number: 022637761

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

REF - 00850798007725 Catalog Number :

Device Description : SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal Cap, AMP, BZO, COC, mAMP, OPI, THC, 25/BX

Device Class : 1

Duns Number: 022637761

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DJO, JXM, DKZ

Prescription Use : Yes

Device Count : 1

CSI - 00850798007787 Catalog Number :

Device Description : CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, Click Seal Cap, AMP500, BAR, CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, Click Seal Cap, AMP500, BAR, BUP, BZO, COC150, mAMP500, MDMA, MOP300, MTD, OXY, PCP, PPX, TCA, THC, 25/BX

Device Class :

Duns Number: 022637761

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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