LIN-ZHI INTERNATIONAL, INC.

Address:2945 Oakmead Village Ct,Santa Clara,CA,95051,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

Calibrators, Drug Mixture (DKB) (7) Drug Mixture Control Materials (DIF) (3)

Premarket Exempt

No Yes

Clear

Multi-Analyte DAU Control Set C, Level 2 Control - B07608580 Catalog Number : 0858

Device Description : 15mL/bottle.Concentration of Multi-Analyte: 187.5 ng/mL benzoylecgonine, 625 ng/ 15mL/bottle.Concentration of Multi-Analyte: 187.5 ng/mL benzoylecgonine, 625 ng/mL d-methamphetamine, 375 ng/mL methadone, 2500 ng/mL morphine, 250 ng/mL oxazepam, and 250 ng/mL secobarbital.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set D, Negative Calibrator - B07608710 Catalog Number : 0871

Device Description : 15 mL/bottle.Concentration: negative (drug-free) human urine

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set D, Low Calibrator - B07608720 Catalog Number : 0872

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 150 ng/mL benzoylecgonine, 500 ng/m 15 mL/bottle.Concentration of Multi-Analyte: 150 ng/mL benzoylecgonine, 500 ng/mL d-methamphetamine, 150 ng/mL morphine, 100 ng/mL oxazepam, and 50 ng/mL oxycodone.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set D, Cutoff Calibrator - B07608730 Catalog Number : 0873

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 300 ng/mL benzoylecgonine, 1000 ng/ 15 mL/bottle.Concentration of Multi-Analyte: 300 ng/mL benzoylecgonine, 1000 ng/mL d-methamphetamine, 300 ng/mL morphine, 200 ng/mL oxazepam, and 100 ng/mL oxycodone.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set D, Intermediate Calibrator - B07608740 Catalog Number : 0874

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1500 ng 15 mL/bottle.Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1500 ng/mL d-methamphetamine, 600 ng/mL morphine, 500 ng/mL oxazepam, and 300 ng/mL oxycodone.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set D, High Calibrator - B07608750 Catalog Number : 0875

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 3000 ng/mL benzoylecgonine, 2000 ng 15 mL/bottle.Concentration of Multi-Analyte: 3000 ng/mL benzoylecgonine, 2000 ng/mL d-methamphetamine, 1000 ng/mL morphine, 1000 ng/mL oxazepam, and 500 ng/mL oxycodone.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Control Set D, Level 1 Control - B07608770 Catalog Number : 0877

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 225 ng/mL benzoylecgonine, 750 ng/m 15 mL/bottle.Concentration of Multi-Analyte: 225 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 225 ng/mL morphine, 150 ng/mL oxazepam, and 75 ng/mL oxycodone.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Control Set D, Level 2 Control - B07608780 Catalog Number : 0878

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 375 ng/mL benzoylecgonine, 1250 ng/ 15 mL/bottle.Concentration of Multi-Analyte: 375 ng/mL benzoylecgonine, 1250 ng/mL d-methamphetamine, 375 ng/mL morphine, 250 ng/mL oxazepam, and 125 ng/mL oxycodone.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set E, Negative Calibrator - B07608910 Catalog Number : 0891

Device Description : 15 mL/bottle.Concentration: negative (drug-free) human urine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set E, Low Calibrator - B07608920 Catalog Number : 0892

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 100 ng/mL secobarbital, 5 ng/mL nor 15 mL/bottle.Concentration of Multi-Analyte: 100 ng/mL secobarbital, 5 ng/mL norbuprenorphine, 150 ng/mL methadone, and 12.5 ng/mL phencyclidine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

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