Twin Spirit Inc.

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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, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (3) Enzyme Immunoassay, Amphetamine (DKZ) (2) Enzyme Immunoassay, Opiates (DJG) (2) Enzyme Immunoassay, Barbiturate (DIS) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

Clear

DrugSmart Dip - 00859144006306 Catalog Number : 30530D

Device Description : AMP/BAR/COC/OPI2000/THC Dipcard

Device Class : 2

Duns Number: 617011296

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

DrugSmart Dip - 00859144006313 Catalog Number : 30640D

Device Description : (BZO/BAR)+AMP+COC+OPI2000+THC DipCard

Device Class : 2

Duns Number: 617011296

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

DrugSmart Dip - 00859144006320 Catalog Number : 30300D

Device Description : COC/MET1000/THC DipCard

Device Class : 2

Duns Number: 617011296

Premarket Exempt : No

Product Code : LDJ, DJC, DIO

Prescription Use : Yes

Device Count : 1

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