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) (3) Enzyme Immunoassay, Phencyclidine (LCM) (2) Enzyme Immunoassay, Opiates (DJG) (1)

Premarket Exempt

No Yes

Clear

Cannabinoids DAU Control, Control - B0760009C0 Catalog Number : 0009c

Device Description : 5mL/bottle.Concentration: 125 ng/mL of 11-nor-Δ9-THC-9-COOH.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Phencyclidine Enzyme Immunoassay - B07600100 Catalog Number : 0010

Device Description : Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.

Device Class : U

Duns Number: 840839190

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

Phencyclidine Enzyme Immunoassay - B07600110 Catalog Number : 0011

Device Description : Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent Large Test Kit.Antibody/Substrate Reagent (R1): 1000 mL.Enzyme Conjugate Reagent (R2): 375 mL.

Device Class : U

Duns Number: 840839190

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

Phencyclidine DAU Calibrator, Low Calibrator - B07600120 Catalog Number : 0012

Device Description : 5mL/bottle.Concentration: 12.5 ng/mL of Phencyclidine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Phencyclidine DAU Calibrator, Cutoff Calibrator - B07600130 Catalog Number : 0013

Device Description : 5mL/bottle.Concentration: 25 ng/mL of Phencyclidine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Phencyclidine DAU Calibrator, Intermediate Calibrator - B07600140 Catalog Number : 0014

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

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Phencyclidine DAU Calibrator, High Calibrator - B07600150 Catalog Number : 0015

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

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Phencyclidine DAU Control, Level 1 Control - B07600170 Catalog Number : 0017

Device Description : 5mL/bottle.Concentration: 18 ng/mL of Phencyclidine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Phencyclidine DAU Control, Level 2 Control - B07600180 Catalog Number : 0018

Device Description : 5mL/bottle.Concentration: 32 ng/mL of Phencyclidine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Opiate Enzyme Immunoassay - B0760020B0 Catalog Number : 0020b

Device Description : Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent Small Test Kit.Antibody/Substrate Reagent (R1): 100 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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