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, Opiates (DJG) (3)

Premarket Exempt

No Yes

Clear

6-Acetylmorphine Enzyme Immunoassay - 00850624008001 Catalog Number : 08240035190

Device Description : 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagen 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme 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

Buprenorphine Enzyme Immunoassay - 00850624008018 Catalog Number : 08362955190

Device Description : 200 tests.Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent 200 tests.Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme 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

Hydrocodone Enzyme Immunoassay - 00850624008025 Catalog Number : 08239819190

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

6-Acetylmorphine Control Set - 00850624008032 Catalog Number : 08240213190

Device Description : 6AM Negative Control 7.5 ng/mL (2 x 15 mL), 6AM Positive Control 12.5 ng/mL (2 x 15 mL).

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

6-Acetylmorphine Qualitative Calibrator Set - 00850624008049 Catalog Number : 08240205190

Device Description : 6AM Cutoff Calibrator 10 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

6-Acetylmorphine Semi-Quantitative Calibrators Set - 00850624008056 Catalog Number : 08240183190

Device Description : 6AM Negative Calibrator 0 ng/mL (1 x 5 mL), 6AM Low Calibrator 5 ng/mL (1 x 5 mL 6AM Negative Calibrator 0 ng/mL (1 x 5 mL), 6AM Low Calibrator 5 ng/mL (1 x 5 mL), 6AM Cutoff Calibrator 10 ng/mL (1 x 5 mL), 6AM Intermediate Calibrator 20 ng/mL (1 x 5 mL), 6AM High Calibrator 40 ng/mL (1 x 5 mL).

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Buprenorphine 5 Control Set - 00850624008063 Catalog Number : 08356670190

Device Description : BUP 5 Negative Control 3 ng/mL (2 x 15 mL), BUP 5 Positive Control 7 ng/mL (2 x 15 mL).

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Buprenorphine 5 Qualitative Calibrator Set - 00850624008070 Catalog Number : 08356661190

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

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Buprenorphine 10 Control Set - 00850624008087 Catalog Number : 08239908190

Device Description : BUP 10 Negative Control 7 ng/mL (2 x 15 mL), BUP 10 Positive Control 13 ng/mL (2 x 15 mL).

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Buprenorphine 10 Qualitative Calibrator Set - 00850624008094 Catalog Number : 08239894190

Device Description : BUP 10 Cutoff Calibrator 10 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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