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

Gas Chromatography, Methamphetamine (LAF) (10) Enzyme Immunoassay, Opiates (DJG) (10) Enzyme Immunoassay, Phencyclidine (LCM) (10) Enzyme Immunoassay, Cannabinoids (LDJ) (10) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (10) Enzyme Immunoassay, Amphetamine (DKZ) (6) Enzyme Immunoassay, Barbiturate (DIS) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Propoxyphene (JXN) (2)

Premarket Exempt

Clear

CRL STAT Cup - 00817815020013 Catalog Number :

Device Description : DOA 5 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/BoxCOC300 MET1000 OPI2000 PCP25 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020037 Catalog Number :

Device Description : DOA 7 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET10 DOA 7 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020051 Catalog Number :

Device Description : DOA 9 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC3 DOA 9 in 1 Test CRL Stat Cup, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 PCP25 THC50

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020075 Catalog Number :

Device Description : DOA 5 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, COC300 MET1000 OPI20 DOA 5 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, COC300 MET1000 OPI2000 PCP25 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020099 Catalog Number :

Device Description : DOA 9 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO30 DOA 9 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 PCP25 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020112 Catalog Number :

Device Description : DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020136 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 MET1000 MTD300 OPI2000 OXY100 PCP25 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020150 Catalog Number :

Device Description : DOA 12 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, THC50 COC300 OPI300 DOA 12 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, THC50 COC300 OPI300 AMP1000 mAMP1000 PCP25 BZO300 BUP10 MDMA500 MTD300 OXY100 BAR300 & SG, CR, OX

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020174 Catalog Number :

Device Description : DOA 6 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 COC300 MET50 DOA 6 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 COC300 MET500 OPI2000 PCP25 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

CRL STAT Cup - 00817815020198 Catalog Number :

Device Description : DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 COC150 MDMA50 DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, AMP500 COC150 MDMA500 MET500 OPI2000 PCP25 THC50 & pH SG OX CR NI

Device Class :

Duns Number: 098268311

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 25

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