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) (8) Thin Layer Chromatography, Methamphetamine (DJC) (8) Enzyme Immunoassay, Benzodiazepine (JXM) (8) Enzyme Immunoassay, Cannabinoids (LDJ) (8) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (8) Enzyme Immunoassay, Methadone (DJR) (7) Enzyme Immunoassay, Amphetamine (DKZ) (6) Enzyme Immunoassay, Barbiturate (DIS) (6) Enzyme Immunoassay, Phencyclidine (LCM) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2) Enzyme Immunoassay, Propoxyphene (JXN) (1)

Premarket Exempt

Clear

CLIAWAIVED INC - 00183278000436 Catalog Number : CLIA-INGM-MC42

Device Description : CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)

Device Class :

Duns Number: 969635304

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

CLIAWAIVED INC - 00183278000443 Catalog Number : CLIA-INGM-MC42S

Device Description : CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Prof CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Only" (Single kit includes 1 device, 1 lancets, 1 dropper, 1 single use buffer, 1 alcohol wipe, 1 procedure card and insert)

Device Class :

Duns Number: 969635304

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

CLIAwaived - 00816610020068 Catalog Number : CLIA-12-RDTC-BUP-A

Device Description : Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD3 Rapid Drug Test Cup for (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000)(MDMA500/OXY100) + CR, NI, PH, BL, SG

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020075 Catalog Number : CLIA-RDDT-13

Device Description : Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/BZO300

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : JXM, LDJ, DJC, DJG, DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020082 Catalog Number : CLIA-14-RDTC-A

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020099 Catalog Number : CLIA-RDDT-52A

Device Description : Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/ Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100 + CR/NI/PH/OX

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020105 Catalog Number : CLIA-RDDT-52

Device Description : Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020112 Catalog Number : CLIA-RDDT-54

Device Description : Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/PCP25/BZO300/MTD300/OXY100/BUP10

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

Product Code : DJR, JXM, LCM, LDJ, DJC, DJG, DIO

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020129 Catalog Number : X07-CLIA-RDDT-70

Device Description : Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/M Rapid Dip Drug Test for COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

CLIAwaived - 00816610020136 Catalog Number : X07-CLIA-RDDT-88

Device Class : 2

Duns Number: 969635304

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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