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) Enzyme Immunoassay, Opiates (DJG) (4) Drug Specific Control Materials (LAS) (2)

Premarket Exempt

No Yes

Clear

LZI Hydrocodone 300 Level 2 Control - 00850624008483 Catalog Number : C68829

Device Description : HYD 300 Level 2 Control 375 ng/mL (1 x 5 mL)

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : Yes

Device Count : 1

LZI Hydrocodone 300 Qualitative Calibrator - 00850624008490 Catalog Number : C68830

Device Description : HYD 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL)

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

LZI Hydrocodone 300 Semi-Quantitative Calibrator Set - 00850624008506 Catalog Number : C68831

Device Description : HYD 300 Low Calibrator 150 ng/mL (1 x 15 mL), HYD 300 Cutoff Calibrator 300 ng/m HYD 300 Low Calibrator 150 ng/mL (1 x 15 mL), HYD 300 Cutoff Calibrator 300 ng/mL (1 x 15 mL), HYD 300 Intermediate Calibrator 500 ng/mL (1 x 15 mL), HYD 300 High Calibrator 800 ng/mL (1 x 15 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Buprenorphine Enzyme Immunoassay - 00850624008513 Catalog Number : 09067752190

Device Description : 240 tests. c pack green, PChAntibody/Substrate Reagent (R1): 1 x 24.0 mLEnzyme C 240 tests. c pack green, PChAntibody/Substrate Reagent (R1): 1 x 24.0 mLEnzyme Conjugate Reagent (R2): 1 x 10.1 mL

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

6-Acetylmorphine Enzyme Immunoassay - 00850624008520 Catalog Number : 09067795190

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Hydrocodone Enzyme Immunoassay - 00850624008537 Catalog Number : 09067736190

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Buprenorphine Enzyme Immunoassay - 00869335000204 Catalog Number : A53684

Device Description : 2 x 100 Test Kit.Antibody/Substrate Reagent (R1): 2 x 20 mL.Enzyme Conjugate Rea 2 x 100 Test Kit.Antibody/Substrate Reagent (R1): 2 x 20 mL.Enzyme Conjugate Reagent (R2): 2 x 5 mL.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Norbuprenorphine DAU Calibrator, Negative Calibrator - 00869335000211 Catalog Number : A53687

Device Description : 5mL/bottle.Concentration: negative (drug-free) human urine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Norbuprenorphine DAU Calibrator, Low Calibrator - 00869335000228 Catalog Number : A68826

Device Description : 5mL/bottle.Concentration: 5 ng/mL of Norbuprenorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Norbuprenorphine DAU Control, Level 1 Control - 00869335000235 Catalog Number : A68824

Device Description : 5mL/bottle.Concentration: 7 ng/mL of Norbuprenorphine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

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