CLINICAL REFERENCE LABORATORY, INC.

Address:8433 Quivira Rd,Lenexa,KS,66215,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) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Amphetamine (DKZ) (9) Gas Chromatography, Methamphetamine (LAF) (9) Enzyme Immunoassay, Methadone (DJR) (8) Enzyme Immunoassay, Barbiturate (DIS) (8) Enzyme Immunoassay, Benzodiazepine (JXM) (8) Enzyme Immunoassay, Propoxyphene (JXN) (8) Enzyme Immunoassay, Phencyclidine (LCM) (7) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2)

Premarket Exempt

Clear

CRL STAT Cup - 00817815020211 Catalog Number :

Device Description : DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, mAMP1000 COC300 THC DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, mAMP1000 COC300 THC50 AMP1000 OPI2000 OXY2000 MTD300 BZO300 BAR300 PCP25 & pH OX SG

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020235 Catalog Number :

Device Description : DOA 11 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC DOA 11 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET500 MTD300 OPI2000 OXY100 PCP25 TCA1000 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020259 Catalog Number :

Device Description : DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC30 DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MDMA500 MET1000 MTD300 OPI300 OXY100 PCP25 THC50 & pH SG OX

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020273 Catalog Number :

Device Description : DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO3 DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MDMA500 MET1000 MTD300 OPI300 OXY100 THC50 & pH SG OX

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020297 Catalog Number :

Device Description : DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 BAR300 BZO30 DOA 10 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 BAR300 BZO300 COC150 MET500 MTD300 OPI2000 OXY100 PCP25 THC50 & OX SG pH CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020310 Catalog Number :

Device Description : DOA 13 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BARB300 BZO300 BU DOA 13 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BARB300 BZO300 BUP10 COC300 THC50 MTD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TCA1000

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Dip Card - 00817815020334 Catalog Number :

Device Description : DOA 9 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 DOA 9 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 PCP25 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Dip Card - 00817815020358 Catalog Number :

Device Description : DOA 10 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO30 DOA 10 in 1 Test CRL Stat Dip Card, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 OXY100 PCP25 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Dip Card - 00817815020372 Catalog Number :

Device Description : DOA 5 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP500 COC150 M DOA 5 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP500 COC150 MET500 OPI2000 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Dip Card - 00817815020396 Catalog Number :

Device Description : DOA 5 in 1 Test CRL Stat Dip Card, CLIA Waived, Sealed Pouch, AMP1000 COC300 OPI DOA 5 in 1 Test CRL Stat Dip Card, CLIA Waived, Sealed Pouch, AMP1000 COC300 OPI2000 PCP25 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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