Cliawaived, Inc.

Address:2721 Loker Ave W,Carlsbad,CA,92010,US

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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, Amphetamine (DKZ) (1) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Cannabinoids (LDJ) (1) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (1) Enzyme Immunoassay, Methadone (DJR) (1) Enzyme Immunoassay, Opiates (DJG) (1) Enzyme Immunoassay, Phencyclidine (LCM) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1) U.V. Spectrometry, Tricyclic Antidepressant Drugs (LFH) (1)

Premarket Exempt

Clear

CLIAwaived - 00816610020143 Catalog Number : CLIA-SDDT-10

Device Description : Single Drug Dipstick Test for THC50

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020150 Catalog Number : CLIA-SDDT-11

Device Description : Single Drug Dipstick Test for COC300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020167 Catalog Number : CLIA-SDDT-13

Device Description : Single Drug Dipstick Test for OPI300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020174 Catalog Number : CLIA-SDDT-14

Device Description : Single Drug Dipstick Test for AMP1000

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020181 Catalog Number : CLIA-SDDT-16

Device Description : Single Drug Dipstick Test for MET500

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020198 Catalog Number : CLIA-SDDT-17

Device Description : Single Drug Dipstick Test for PCP25

Device Class : U

Duns Number: 969635304

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020204 Catalog Number : CLIA-SDDT-18

Device Description : Single Drug Dipstick Test for BZO300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020211 Catalog Number : CLIA-SDDT-19

Device Description : Single Drug Dipstick Test for BAR300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020228 Catalog Number : CLIA-SDDT-20

Device Description : Single Drug Dipstick Test for MTD300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020235 Catalog Number : CLIA-SDDT-21

Device Description : Single Drug Dipstick Test for TCA1000

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : LFH

Prescription Use : Yes

Device Count : 1

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