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) (8) Drug Mixture Control Materials (DIF) (2)

Premarket Exempt

No Yes

Clear

Multi-Analyte DAU Calibrator Set E, Cutoff Calibrator - B07608930 Catalog Number : 0893

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 200 ng/mL secobarbital, 10 ng/mL no 15 mL/bottle.Concentration of Multi-Analyte: 200 ng/mL secobarbital, 10 ng/mL norbuprenorphine, 300 ng/mL methadone, and 25 ng/mL phencyclidine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set E, Intermediate Calibrator - B07608940 Catalog Number : 0894

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 500 ng/mL secobarbital, 20 ng/mL no 15 mL/bottle.Concentration of Multi-Analyte: 500 ng/mL secobarbital, 20 ng/mL norbuprenorphine, 600 ng/mL methadone, and 50 ng/mL phencyclidine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set E, High Calibrator - B07608950 Catalog Number : 0895

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 1000 ng/mL secobarbital, 40 ng/mL n 15 mL/bottle.Concentration of Multi-Analyte: 1000 ng/mL secobarbital, 40 ng/mL norbuprenorphine, 1000 ng/mL methadone, and 100 ng/mL phencyclidine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Control Set E, Level 1 Control - B07608970 Catalog Number : 0897

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 150 ng/mL secobarbital, 7 ng/mL nor 15 mL/bottle.Concentration of Multi-Analyte: 150 ng/mL secobarbital, 7 ng/mL norbuprenorphine, 225 ng/mL methadone, and 18 ng/mL phencyclidine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Control Set E, Level 2 Control - B07608980 Catalog Number : 0898

Device Description : 15 mL/bottle.Concentration of Multi-Analyte: 250 ng/mL secobarbital, 13 ng/mL no 15 mL/bottle.Concentration of Multi-Analyte: 250 ng/mL secobarbital, 13 ng/mL norbuprenorphine, 375 ng/mL methadone, and 32 ng/mL phencyclidine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Multi-Analyte DAU Calibrator Set F, Negative Calibrator - B07609110 Catalog Number : 0911

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 F, Low Calibrator - B07609120 Catalog Number : 0912

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 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 F, Cutoff Calibrator - B07609130 Catalog Number : 0913

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 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 F, Intermediate Calibrator - B07609140 Catalog Number : 0914

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 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 Calibrator Set F, High Calibrator - B07609150 Catalog Number : 0915

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 800 ng/mL oxycodone.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

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