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 Specific (DLJ) (4) Drug Specific Control Materials (LAS) (4) Gas Chromatography, Methamphetamine (LAF) (2)

Premarket Exempt

No Yes

Clear

Oral Fluid Amphetamine Control, Level 1 Control - B076S0046B0 Catalog Number : S0046b

Device Description : 5 mL/bottle.Concentration: 37.5 ng/mL of Amphetamine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Oral Fluid Amphetamine Control, Level 2 Control - B076S0047B0 Catalog Number : S0047b

Device Description : 5 mL/bottle.Concentration: 62.5 ng/mL of Amphetamine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Enzyme Immunoassay - B076S0050B0 Catalog Number : S0050b

Device Description : Small Test Kit.Antibody/Substrate Reagent (R1): 75 mL.Enzyme Conjugate Reagent ( Small Test Kit.Antibody/Substrate Reagent (R1): 75 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Enzyme Immunoassay - B076S0051B0 Catalog Number : S0051b

Device Description : Large Test Kit.Antibody/Substrate Reagent (R1): 750 mL.Enzyme Conjugate Reagent Large Test Kit.Antibody/Substrate Reagent (R1): 750 mL.Enzyme Conjugate Reagent (R2): 375 mL.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Calibrator, Low Calibrator - B076S0052B0 Catalog Number : S0052b

Device Description : 5 mL/bottle.Concentration: 20 ng/mL of Methamphetamine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Calibrator, Cutoff Calibrator - B076S0053B0 Catalog Number : S0053b

Device Description : 5 mL/bottle.Concentration: 50 ng/mL of Methamphetamine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Calibrator, Intermediate Calibrator - B076S0054B0 Catalog Number : S0054b

Device Description : 5 mL/bottle.Concentration: 100 ng/mL of Methamphetamine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Calibrator, High Calibrator - B076S0055B0 Catalog Number : S0055b

Device Description : 5 mL/bottle.Concentration: 140 ng/mL of Methamphetamine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Control, Level 1 Control - B076S0056B0 Catalog Number : S0056b

Device Description : 5 mL/bottle.Concentration: 37.5 ng/mL of Methamphetamine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Oral Fluid Methamphetamine Control, Level 2 Control - B076S0057B0 Catalog Number : S0057b

Device Description : 5 mL/bottle.Concentration: 62.5 ng/mL of Methamphetamine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

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