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) (2) Enzyme Immunoassay, Opiates (DJG) (2) Drug Mixture Control Materials (DIF) (1) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

No Yes

Clear

Methadone Metabolite 100 Control Set - 00850624008209 Catalog Number : 08735620190

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

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Methadone Metabolite 300 Qualitative Calibrator Set - 00850624008216 Catalog Number : 08735654190

Device Description : EDDP 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

Methadone Metabolite 300 Semi-Quantitative Calibrators Set - 00850624008223 Catalog Number : 08735662190

Device Description : EDDP 300 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 300 Low Calibrator 150 ng/ EDDP 300 Negative Calibrator 0 ng/mL (1 x 5 mL), EDDP 300 Low Calibrator 150 ng/mL (1 x 5 mL), EDDP 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL), EDDP 300 Intermediate Calibrator 600 ng/mL (1 x 5 mL), EDDP 300 High Calibrator 1000 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 300 Control Set - 00850624008230 Catalog Number : 08735689190

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

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Methadone Metabolite Enzyme Immunoassay - 00850624008247 Catalog Number : 09067671190

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 : DJR

Prescription Use : Yes

Device Count : 1

Fentanyl II Enzyme Immunoassay - 00850624008254 Catalog Number : 09310002190

Device Description : 200 tests. c 501/502, PChAntibody/Substrate Reagent (R1): 1 x 24.0 mLEnzyme Conj 200 tests. c 501/502, 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

Fentanyl II Enzyme Immunoassay - 00850624008261 Catalog Number : 09444360190

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Fentanyl Qualitative Calibrator Set - 00850624008278 Catalog Number : 09330097190

Device Description : FEN 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

DAT Opiates Multi Control I Set - 00850624008285 Catalog Number : 09330119190

Device Description : Multi-analyte Negative Control (2 x 15 mL)Multi-analyte Positive Control (2 x 15 mL)

Device Class : 1

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

LZI Universal Negative Calibrator - 00850624008292 Catalog Number : C68807

Device Description : NEG Calibrator 0 ng/mL (1 x 5 mL)

Device Class : 2

Duns Number: 840839190

Premarket Exempt : Yes

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

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