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) (5) Drug Specific Control Materials (LAS) (2) Enzyme Immunoassay, Cannabinoids (LDJ) (2) Enzyme Immunoassay, Opiates (DJG) (1)

Premarket Exempt

No Yes

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Oral Fluid Cannabinoid Enzyme Immunoassay - B076S0070C0 Catalog Number : S0070c

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 : LDJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Enzyme Immunoassay - B076S0071C0 Catalog Number : S0071c

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 : LDJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Calibrator, Negative Calibrator - B076S0072C0 Catalog Number : S0072c

Device Description : 15 mL/bottle.Concentration: negative (drug-free) OF THC calibrator buffer.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Calibrator, Low Calibrator - B076S0073C0 Catalog Number : S0073c

Device Description : 15 mL/bottle.Concentration: 2 ng/mL of Δ9-THC.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Calibrator, Cutoff Calibrator - B076S0074C0 Catalog Number : S0074c

Device Description : 15 mL/bottle.Concentration: 4 ng/mL of Δ9-THC.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Calibrator, Intermediate Calibrator - B076S0075C0 Catalog Number : S0075c

Device Description : 15 mL/bottle.Concentration: 6 ng/mL of Δ9-THC.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Calibrator, High Calibrator - B076S0076C0 Catalog Number : S0076c

Device Description : 15 mL/bottle.Concentration: 12 ng/mL of Δ9-THC.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Control, Level 1 Control - B076S0077C0 Catalog Number : S0077c

Device Description : 15 mL/bottle.Concentration: 3 ng/mL of Δ9-THC.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Oral Fluid Cannabinoid Control, Level 2 Control - B076S0078C0 Catalog Number : S0078c

Device Description : 15 mL/bottle.Concentration: 5 ng/mL of Δ9-THC.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Enzyme Immunoassay - B076S02900 Catalog Number : S0290

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 : DJG

Prescription Use : Yes

Device Count : 1

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