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) (10) Gas Chromatography, Methamphetamine (LAF) (9) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (9) Enzyme Immunoassay, Methadone (DJR) (8) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Enzyme Immunoassay, Cannabinoids (LDJ) (5) Enzyme Immunoassay, Barbiturate (DIS) (4) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Thin Layer Chromatography, Methamphetamine (DJC) (1)

Premarket Exempt

Clear

CLIAwaived - 00816610020785 Catalog Number : CLIA-IDTC-11-NTHC

Device Description : CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BA CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, TCA)-(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020808 Catalog Number : CLIA-IDTC-12BUPa

Device Description : CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAM CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, BUP + Cr, SG, OX)-(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020822 Catalog Number : CLIA-IDTC-5-60527a

Device Description : CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 100 CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020846 Catalog Number : CLIA-IDTC-5-60579

Device Description : CLIAwaived,Inc. IDTC- 5 Panel Drug Test Cup (COC,mAMP,OPI300, OXY, MTD)-(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJR, DJG, LAF, DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020860 Catalog Number : CLIA-IDTC-5-60527

Device Description : CLIAwaived,Inc. IDTC- 5 Panel Cup (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : LDJ, DJG, LAF, DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020884 Catalog Number : CLIA-IDTC-5-65569

Device Description : CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP CLIAwaived,Inc. One Step Drug Test Cup-5 panel with Adulterants (COC,OPI300,mAMP,OXY, MTD + Cr, SG, OX) -(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJR, LAF, DJG, DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020914 Catalog Number : CLIA-IDTC-6-60669

Device Description : CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : LFG, DJR, DIS, JXM, DJG

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020921 Catalog Number : CLIA-IDTC-7-60717

Device Description : CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mA CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO) -(25T/KIT)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020938 Catalog Number : CLIA-IDTC-7BUP

Device Description : CLIAwaived,Inc. IDTC- 7 Panel Drug Screen (CR,SG,OX) for (COC/MET/MOP/MTD/BZO/OXY/BUP)

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610021058 Catalog Number : CLIA-12-RDTC-A

Device Description : Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AM Rapid Drug Test Cup for (THC/COC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Adulteration Tests CR, NI, PH, BL, SG

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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