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, Opiates (DJG) (1)

Premarket Exempt

No Yes

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Oral Fluid 6-Acetylmorphine Enzyme Immunoassay - B076S02910 Catalog Number : S0291

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 : DJG

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control - B076S02920 Catalog Number : S0292

Device Description : 5 mL/bottle.Concentration: 2 ng/mL of 6-Acetylmorphine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS, DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Calibrator, Cutoff Calibrator - B076S02930 Catalog Number : S0293

Device Description : 5 mL/bottle.Concentration: 4 ng/mL of 6-Acetylmorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Calibrator, Intermediate Calibrator - B076S02940 Catalog Number : S0294

Device Description : 5 mL/bottle.Concentration: 10 ng/mL of 6-Acetylmorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Calibrator, High Calibrator - B076S02950 Catalog Number : S0295

Device Description : 5 mL/bottle.Concentration: 20 ng/mL of 6-Acetylmorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Control, Level 2 Control - B076S02970 Catalog Number : S0297

Device Description : 5 mL/bottle.Concentration: 6 ng/mL of 6-Acetylmorphine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Oral Fluid 6-Acetylmorphine Calibrator, Negative Calibrator - B076S02980 Catalog Number : S0298

Device Description : 5 mL/bottle.Concentration: 0 ng/mL of 6-Acetylmorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

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