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) (7) Drug Specific Control Materials (LAS) (2) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

No Yes

Clear

Buprenorphine Semi-Quantitative Calibrators Set - 00850624008100 Catalog Number : 08239886190

Device Description : BUP Negative Calibrator 0 ng/mL (1 x 5 mL), BUP Low/Cutoff Calibrator #1 5 ng/mL BUP Negative Calibrator 0 ng/mL (1 x 5 mL), BUP Low/Cutoff Calibrator #1 5 ng/mL (1 x 5 mL), BUP Cutoff Calibrator #2 10 ng/mL (1 x 5 mL), BUP Intermediate Calibrator #1 20 ng/mL (1 x 5 mL), BUP Intermediate Calibrator #2 40 ng/mL (1 x 5 mL), BUP High Calibrator 75 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Hydrocodone 100 Control Set - 00850624008117 Catalog Number : 08304742190

Device Description : HYD 100 Negative Control 75 ng/mL (2 x 15 mL), HYD 100 Positive Control 125 ng/m HYD 100 Negative Control 75 ng/mL (2 x 15 mL), HYD 100 Positive Control 125 ng/mL (2 x 15 mL).

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Hydrocodone 100 Qualitative Calibrator Set - 00850624008124 Catalog Number : 08304734190

Device Description : HYD 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Hydrocodone 300 Control Set - 00850624008131 Catalog Number : 08239851190

Device Description : HYD 300 Negative Control 225 ng/mL (2 x 15 mL), HYD 300 Positive Control 375 ng/ HYD 300 Negative Control 225 ng/mL (2 x 15 mL), HYD 300 Positive Control 375 ng/mL (2 x 15 mL).

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Hydrocodone 300 Qualitative Calibrator Set - 00850624008148 Catalog Number : 08239843190

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

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Hydrocodone 100 Semi-Quantitative Calibrators Set - 00850624008155 Catalog Number : 08304718190

Device Description : HYD 100 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 100 Low Calibrator 50 ng/mL HYD 100 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 100 Low Calibrator 50 ng/mL (1 x 5 mL), HYD 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL), HYD 100 Intermediate Calibrator 150 ng/mL (1 x 5 mL), HYD 100 High Calibrator 300 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Hydrocodone 300 Semi-Quantitative Calibrators Set - 00850624008162 Catalog Number : 08239827190

Device Description : HYD 300 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 300 Low Calibrator 150 ng/mL HYD 300 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 300 Low Calibrator 150 ng/mL (1 x 5 mL), HYD 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL), HYD 300 Intermediate Calibrator 500 ng/mL (1 x 5 mL), HYD 300 High Calibrator 800 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Methadone Metabolite Enzyme Immunoassay - 00850624008179 Catalog Number : 08735581190

Device Description : 200 tests. Antibody/Substrate Reagent (R1): 1 x 21.58 mLEnzyme Conjugate Reagent 200 tests. Antibody/Substrate Reagent (R1): 1 x 21.58 mLEnzyme Conjugate Reagent (R2): 1 x 9.85 mL

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

Methadone Metabolite 100 Qualitative Calibrator Set - 00850624008186 Catalog Number : 08735590190

Device Description : EDDP 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Methadone Metabolite 100 Semi-Quantitative Calibrators Set - 00850624008193 Catalog Number : 08735603190

Device Description : EDDP 100 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 100 Low Calibrator 50 ng/m EDDP 100 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 100 Low Calibrator 50 ng/mL (1 x 5 mL), EDDP 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL), EDDP 100 Intermediate Calibrator 250 ng/mL (1 x 5 mL), EDDP 100 High Calibrator 500 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

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