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, Opiates (DJG) (7) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Cannabinoids (LDJ) (4) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (4) Thin Layer Chromatography, Methamphetamine (DJC) (3) Enzyme Immunoassay, Barbiturate (DIS) (3) Enzyme Immunoassay, Phencyclidine (LCM) (2) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2) Enzyme Immunoassay, Amphetamine (DKZ) (2)

Premarket Exempt

Clear

CLIAwaived - 00816610020242 Catalog Number : CLIA-SDDT-22

Device Description : Single Drug Dipstick Test for MDMA500

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJC

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020259 Catalog Number : CLIA-SDDT-23

Device Description : Single Drug Dipstick Test for OXY100

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020266 Catalog Number : CLIA-SDDT-25

Device Description : Single Drug Dipstick Test for BUP10

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

CLIAWAIVED INC - 00816610020402 Catalog Number : THYROCHEK-120-A-KIT

Device Description : Thyrochek One-Step Whole Blood Rapid TSH Assay

Device Class :

Duns Number: 969635304

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

CLIAWAIVED INC - 00816610020440 Catalog Number : CLIA-TSH-120-A-KIT

Device Description : CLIAWaived Inc. Thyroid Test Rapid TSH cassette (whole blood)

Device Class :

Duns Number: 969635304

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

CLIAwaived - 00816610020624 Catalog Number : CLIA-SDDT-QF08

Device Description : Single Drug Dipstick Test for BZO300/BAR300/MTD300/OXY100

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJG, DJR, DIS, JXM

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020631 Catalog Number : CLIA-SDDT-QF09

Device Description : Single Drug Dipstick Test for THC50/COC300/OPI300/BZO300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : JXM, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020648 Catalog Number : CLIA-SDDT-QF10

Device Description : Single Drug Dipstick Test for THC50/COC300/OPI300/MTD300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJR, DJG, DIO, LDJ

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020655 Catalog Number : CLIA-RDTC-12

Device Description : Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDM Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) Includes adulterant testing for Creatinine, Nitrite, pH, Bleach and SG

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020662 Catalog Number : CLIA-RDTC-12-02

Device Description : Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDM Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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