Lin-Zhi International, Inc

FDA Filings

This page includes the latest FDA filings for Lin-Zhi International, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Lin-Zhi International, Inc.
LZI Cotinine II Enzyme Immunoassay2019-11-21
Lin-Zhi International, Inc
LZI Methadone II Enzyme Immunoassay2019-10-04
Lin-Zhi International, Inc.
LZI Fentanyl Enzyme Immunoassay2018-12-03
Lin-Zhi International, Inc.
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 And 300) Calibrators2017-06-26
Lin-Zhi International, Inc.
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS2014-02-21
Lin-Zhi International, Inc.
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 02212003-10-03

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Lin-Zhi International, Inc.
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay2018-04-20

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Methadone Metabolite 100 DAU Calibrator, High Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 100 DAU Calibrator, Intermediate Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 100 DAU Calibrator, Cutoff Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 100 DAU Calibrator, Low Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 300 DAU Calibrator, High Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 300 DAU Calibrator, Intermediate Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 300 DAU Calibrator, Cutoff Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite 300 DAU Calibrator, Low Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite Enzyme Immunoassay
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Methadone Metabolite Enzyme Immunoassay
LIN-ZHI INTERNATIONAL, INC.2019-10-28
Carisprodol Metabolite (Meprobamate) DAU Control, Level 2 Control
LIN-ZHI INTERNATIONAL, INC.2019-07-03
Carisprodol Metabolite (Meprobamate) DAU Control, Level 1 Control
LIN-ZHI INTERNATIONAL, INC.2019-07-03
Carisprodol Metabolite (Meprobamate) DAU Calibrator, High Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-07-03
Carisprodol Metabolite (Meprobamate) DAU Calibrator, Intermediate Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-07-03
Carisprodol Metabolite (Meprobamate) DAU Calibrator, Cutoff Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-07-03
Carisprodol Metabolite (Meprobamate) DAU Calibrator, Low Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-07-03
Multi-Analyte DAU Control Set F, Level 2 Control
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Control Set F, Level 1 Control
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set F, High Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set F, Intermediate Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set F, Cutoff Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set F, Low Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set F, Negative Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Control Set E, Level 2 Control
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Control Set E, Level 1 Control
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set E, High Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set E, Intermediate Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set E, Cutoff Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set E, Low Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set E, Negative Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Control Set D, Level 2 Control
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Control Set D, Level 1 Control
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set D, High Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set D, Intermediate Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03
Multi-Analyte DAU Calibrator Set D, Cutoff Calibrator
LIN-ZHI INTERNATIONAL, INC.2019-04-03

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