LIN-ZHI INTERNATIONAL, INC.

Address:2945 Oakmead Village Ct,Santa Clara,CA,95051,US

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Filters

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) (4)

Premarket Exempt

No Yes

Clear

Norbuprenorphine DAU Calibrator, Cutoff Calibrator - 00869335000242 Catalog Number : A68827

Device Description : 5mL/bottle.Concentration: 10 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 2 Control - 00869335000259 Catalog Number : A68825

Device Description : 5mL/bottle.Concentration: 13 ng/mL of Norbuprenorphine.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Norbuprenorphine DAU Calibrator, Intermediate Calibrator #1 - 00869335000266 Catalog Number : A68828

Device Description : 5mL/bottle.Concentration: 20 ng/mL of Norbuprenorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Norbuprenorphine DAU Calibrator, Intermediate Calibrator #2 - 00869335000273 Catalog Number : A68829

Device Description : 5mL/bottle.Concentration: 40 ng/mL of Norbuprenorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Norbuprenorphine DAU Calibrator, High Calibrator - 00869335000280 Catalog Number : A68830

Device Description : 5mL/bottle.Concentration: 100 ng/mL of Norbuprenorphine.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Negative DAU Calibrator - B07600010 Catalog Number : 0001

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

Cannabinoids DAU Calibrator, Negative Calibrator - B0760002C0 Catalog Number : 0002c

Device Description : 5mL/bottle.Concentration: 0 ng/mL of 11-nor-Δ9-THC-9-COOH.

Device Class : 2

Duns Number: 840839190

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

Cannabinoids DAU Control, Control - B0760006C0 Catalog Number : 0006c

Device Description : 5mL/bottle.Concentration: 18.75 ng/mL of 11-nor-Δ9-THC-9-COOH

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

Cannabinoids DAU Calibrator/Control, Calibrator/Control - B0760007C0 Catalog Number : 0007c

Device Description : 5mL/bottle.Concentration: 37.5 ng/mL of 11-nor-Δ9-THC-9-COOH.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS, DLJ

Prescription Use : Yes

Device Count : 1

Cannabinoids DAU Control, Control - B0760008C0 Catalog Number : 0008c

Device Description : 5mL/bottle.Concentration: 62.5 ng/mL of 11-nor-Δ9-THC-9-COOH.

Device Class : 1

Duns Number: 840839190

Premarket Exempt : No

Product Code : LAS

Prescription Use : Yes

Device Count : 1

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