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

Drug Specific Control Materials (LAS) (5) Calibrators, Drug Specific (DLJ) (3) Enzyme Immunoassay, Opiates (DJG) (2)

Premarket Exempt

No Yes

Clear

LZI Fentanyl (Q) Enzyme Immunoassay - 00850624008353 Catalog Number : C68808

Device Description : Antibody/Substrate Reagent (R1): 100 mLEnzyme Conjugate Reagent (R2): 37.5 mL

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

LZI Norfentanyl (Q) Qualitative Calibrator - 00850624008360 Catalog Number : C68815

Device Description : NFEN Cutoff Calibrator 5 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 Norfentanyl Level 1 Control - 00850624008407 Catalog Number : C68821

Device Description : NFEN Level 1 Control 3.75 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 Norfentanyl Level 2 Control - 00850624008414 Catalog Number : C68822

Device Description : NFEN Level 2 Control 6.25 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 Enzyme Immunoassay - 00850624008421 Catalog Number : C68823

Device Description : Antibody/Substrate Reagent (R1): 100 mLEnzyme Conjugate Reagent (R2): 37.5 mL

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

LZI Hydrocodone 100 Qualitative Calibrator - 00850624008438 Catalog Number : C68824

Device Description : HYD 100 Cutoff Calibrator 100 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 100 Semi-Quantitative Calibrator Set - 00850624008445 Catalog Number : C68825

Device Description : HYD 100 Low Calibrator 50 ng/mL (1 x 15 mL)HYD 100 Cutoff Calibrator 100 ng/mL ( HYD 100 Low Calibrator 50 ng/mL (1 x 15 mL)HYD 100 Cutoff Calibrator 100 ng/mL (1 x 15 mL)HYD 100 Intermediate Calibrator 150 ng/mL (1 x 15 mL)HYD 100 High Calibrator 300 ng/mL (1 x 15 mL)

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

LZI Hydrocodone 100 Level 1 Control - 00850624008452 Catalog Number : C68826

Device Description : HYD 100 Level 1 Control 75 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 100 Level 2 Control - 00850624008469 Catalog Number : C68827

Device Description : HYD 100 Level 2 Control 125 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 Level 1 Control - 00850624008476 Catalog Number : C68828

Device Description : HYD 300 Level 1 Control 225 ng/mL (1 x 5 mL)

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : Yes

Device Count : 1

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