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Lin-Zhi International, Inc.

United States·US-MF-000003373

Last updated September 17, 2026

About

Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara, California 95051 USA

From the manufacturer's own website, in their original language. Source

Information

Country: United States
Address: 2945, Oakmead Village Court, Santa Clara, United States
Website: lin-zhi.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Cassie Bai
EUDAMED SRN: US-MF-000003373
FDA FEI Number: 3003610499
DUNS Number: —

Catalogue (425)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
Methamphetamine DAU Control, Level 2 Control	0358	FDA UDI	Class I	Active
LZI Cotinine II Level 2 Control	0528	FDA UDI	Class I	Active
Hydrocodone 100 Semi-Quantitative Calibrators Set	08304718190	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set A, Cutoff Calibrator	0813	FDA UDI	Class II	Active
Fentanyl II Enzyme Immunoassay	0570	FDA UDI	Class II	Active
Buprenorphine Enzyme Immunoassay	0270	FDA UDI	Class II	Active
Hydrocodone 100 DAU Control, Level 2 Control	0388	FDA UDI	Class I	Active
Barbiturate Enzyme Immunoassay	0141	FDA UDI	Class II	Active
Benzodiazepine Enzyme Immunoassay	0131	FDA UDI	Class II	Active
Hydrocodone 300 Semi-Quantitative Calibrators Set	08239827190	FDA UDI	Class II	Active
Phencyclidine DAU Calibrator, High Calibrator	0015	FDA UDI	Class II	Active
Oral Fluid Cannabinoid Enzyme Immunoassay	S0070c	FDA UDI	Class II	Active
Cocaine Metabolite 150 Enzyme Immunoassay	0341	FDA UDI	Class II	Active
Oral Fluid Amphetamine Calibrator, Low Calibrator	S0042b	FDA UDI	Class II	Active
Cocaine Metabolite Enzyme Immunoassay	0031	FDA UDI	Class II	Active
Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay	0371	FDA UDI	Class II	Active
Oxycodone DAU Calibrator, Intermediate Calibrator	0248b	FDA UDI	Class II	Active
LZI Tramadol Enzyme Immunoassay	0410	FDA UDI	Class II	Active
LZI Norfentanyl Level 2 Control	C68822	FDA UDI	Class I	Active
Benzodiazepine DAU Calibrator, Calibrator #5	0135	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set A, Intermediate Calibrator	0814	FDA UDI	Class II	Active
Fentanyl II Enzyme Immunoassay	0571	FDA UDI	Class II	Active
Oral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control	S0292	FDA UDI	Class I	Active
LZI Hydrocodone 100 Level 1 Control	C68826	FDA UDI	Class I	Active
6-Acetylmorphine DAU Calibrator, Negative Calibrator	0299	FDA UDI	Class II	Active
Propoxyphene DAU Calibrator, Intermediate Calibrator	0124	FDA UDI	Class II	Active
Buprenorphine Enzyme Immunoassay	A53684	FDA UDI	Class II	Active
Barbiturate Enzyme Immunoassay	0140	FDA UDI	Class II	Active
Ethyl Alcohol Enzymatic Assay	0221	FDA UDI	Class II	Active
Methadone DAU Calibrator, High Calibrator	0115	FDA UDI	Class II	Active
Phencyclidine DAU Control, Level 1 Control	0017	FDA UDI	Class I	Active
Cannabinoids DAU Calibrator, Calibrator	0077c	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set B, Level 2 Control	0838	FDA UDI	Class I	Active
Cannabinoids DAU Calibrator, Calibrator	0075c	FDA UDI	Class II	Active
LZI Oxycodone 100 Cutoff Calibrator	0613	FDA UDI	Class II	Active
LZI Oxycodone 100 Level 2 Control	0618	FDA UDI	Class I	Active
Methadone Metabolite 300 DAU Calibrator, Intermediate Calibrator	0194b	FDA UDI	Class II	Active
LZI Universal Negative Calibrator	C68807	FDA UDI	Class II	Active
6-Acetylmorphine Qualitative Calibrator Set	08240205190	FDA UDI	Class II	Active
LZI Hydrocodone 100 Level 2 Control	C68827	FDA UDI	Class I	Active
Multi-Analyte DAU Calibrator Set D, Low Calibrator	0872	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set D, Intermediate Calibrator	0874	FDA UDI	Class II	Active
Fentanyl II Enzyme Immunoassay	09444360190	FDA UDI	Class II	Active
Amphetamines Enzyme Immunoassay	0041	FDA UDI	Class II	Active
Phencyclidine Enzyme Immunoassay	0010	FDA UDI	U	Active
Propoxyphene Enzyme Immunoassay	0120	FDA UDI	Class II	Active
LZI Cotinine II Low Calibrator	0522	FDA UDI	Class II	Active
Methamphetamine Enzyme Immunoassay	0350	FDA UDI	Class II	Active
Hydrocodone Enzyme Immunoassay	08239819190	FDA UDI	Class II	Active
Methadone Metabolite 300 DAU Control, Level 1 Control	0197b	FDA UDI	Class I	Active

Related Companies

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 11, 2019	Z-1256-2019	—	terminated	Shelf life of the product may be reduced due to degradation of the assay.
Feb 18, 2014	Z-1270-2014	—	terminated	Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
Feb 6, 2014	Z-1178-2014	—	terminated	Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
Feb 6, 2014	Z-1179-2014	—	terminated	Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.
Oct 3, 2013	Z-0386-2014	—	terminated	Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.
Oct 11, 2011	Z-0847-2012	—	terminated	Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
Sep 8, 2011	Z-0846-2012	—	terminated	Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.
Aug 23, 2011	Z-0868-2012	—	terminated	Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.
Aug 5, 2011	Z-0838-2012	—	terminated	Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators.