Is this your brand? Sign in to claim ownership.

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

What Lin-Zhi International, Inc. makes

Lin-Zhi International, Inc. manufactures in vitro diagnostic (IVD) reagents, calibrators, and controls for the detection of drugs of abuse. Their product portfolio includes enzyme immunoassays and calibration sets for substances such as opiates, buprenorphine, oxycodone, cannabinoids, EDDP, 6-acetyl morphine, methamphetamine, cotinine, fentanyl, barbiturates, benzodiazepines, and phencyclidine.

The company is based in the United States, and its devices are categorized as Class I, Class II, and Class U. These products are listed in the FDA Global Unique Device Identification Database (GUDID).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Lin-Zhi International, Inc. manufacture?

Lin-Zhi International, Inc. manufactures in vitro diagnostic (IVD) reagents, calibrators, and controls designed for the detection of drugs of abuse. Their product portfolio includes enzyme immunoassays and calibration sets for a wide range of substances, including opiates, buprenorphine, oxycodone, cannabinoids, EDDP, 6-acetyl morphine, methamphetamine, cotinine, fentanyl, barbiturates, benzodiazepines, and phencyclidine.

Where is Lin-Zhi International, Inc. based?

Lin-Zhi International, Inc. is based in the United States. This location information is provided as part of the company profile to identify the manufacturer's primary base of operations.

How are the devices from Lin-Zhi International, Inc. classified?

The devices manufactured by Lin-Zhi International, Inc. are categorized under three distinct regulatory classifications: Class I, Class II, and Class U. These classifications are assigned based on the regulatory framework applicable to the specific IVD reagents, calibrators, and controls produced by the company.

Which registries list the devices produced by this company?

The devices produced by Lin-Zhi International, Inc. are listed in the FDA Global Unique Device Identification Database (GUDID). This registry is used to track medical devices through their unique device identifiers to ensure transparency and regulatory oversight.

AI-generated from registry data and not verified by a human reviewer.

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 5 of 9

Device	Model / Reference	Registries	Class	Status
Oral Fluid Amphetamine Enzyme Immunoassay	S0041b	FDA UDI	Class II	Active
LZI Fentanyl (Q) Enzyme Immunoassay	C68808	FDA UDI	Class II	Active
LZI Cotinine II Enzyme Immunoassay	0520	FDA UDI	Class I	Active
Hydrocodone 300 Control Set	08239851190	FDA UDI	Class I	Active
Opiate 2000 DAU Control, Level 1 Control	0337	FDA UDI	Class I	Active
Cocaine Metabolite 150 DAU Control, Level 2 Control	0348	FDA UDI	Class I	Active
6-Acetylmorphine Enzyme Immunoassay	09067795190	FDA UDI	Class II	Active
Methadone Metabolite DAU Control, Level 2 Control	0198	FDA UDI	Class II	Active
Ecstasy DAU Calibrator, High Calibrator	0165	FDA UDI	Class II	Active
Amphetamines DAU Control, Level 1 Control	0047	FDA UDI	Class I	Active
Oral Fluid Amphetamine Calibrator, High Calibrator	S0045b	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set B, Low Calibrator	0832	FDA UDI	Class II	Active
Hydrocodone 300 Qualitative Calibrator Set	08239843190	FDA UDI	Class II	Active
Norbuprenorphine DAU Calibrator, Cutoff Calibrator #2	0275	FDA UDI	Class II	Active
LZI Cotinine II High Calibrator	0525	FDA UDI	Class II	Active
Phencyclidine DAU Calibrator, Cutoff Calibrator	0013	FDA UDI	Class II	Active
Oxycodone Enzyme Immunoassay	0241b	FDA UDI	Class II	Active
Oral Fluid 6-Acetylmorphine Calibrator, Cutoff Calibrator	S0293	FDA UDI	Class II	Active
Cannabinoids DAU Control, Control	0009c	FDA UDI	Class I	Active
Multi-Analyte DAU Control Set F, Level 1 Control	0917	FDA UDI	Class I	Active
LZI Norfentanyl Level 1 Control	C68821	FDA UDI	Class I	Active
Cannabinoid Enzyme Immunoassay	0070c	FDA UDI	Class II	Active
Buprenorphine 10 Control Set	08239908190	FDA UDI	Class I	Active
Carisprodol Metabolite (Meprobamate) DAU Calibrator, High Calibrator	0375	FDA UDI	Class II	Active
LZI Oxycodone 300 High Calibrator	0625	FDA UDI	Class II	Active
LZI Cotinine II Intermediate Calibrator	0524	FDA UDI	Class II	Active
Norbuprenorphine DAU Calibrator, Low Calibrator	A68826	FDA UDI	Class II	Active
LZI Tramadol Intermediate Calibrator	0414	FDA UDI	Class II	Active
Methadone Metabolite 100 DAU Calibrator, Cutoff Calibrator	0203b	FDA UDI	Class II	Active
Amphetamines 500 DAU Calibrator, Intermediate Calibrator	0104	FDA UDI	Class II	Active
Opiate 2000 Enzyme Immunoassay	0330	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set D, Negative Calibrator	0871	FDA UDI	Class II	Active
Hydrocodone 300 DAU Control, Level 2 Control	0398	FDA UDI	N/A	Active
Hydrocodone 100 DAU Calibrator, Low Calibrator	0382	FDA UDI	Class II	Active
Propoxyphene DAU Control, Level 2 Control	0128	FDA UDI	Class I	Active
Methamphetamine Enzyme Immunoassay	0351	FDA UDI	Class II	Active
Benzodiazepine DAU Control , Control 4	0136	FDA UDI	Class I	Active
Oxycodone DAU Calibrator, Cutoff Calibrator #2	0246b	FDA UDI	Class II	Active
Hydrocodone 300 DAU Calibrator, Cutoff Calibrator	0393	FDA UDI	Class II	Active
Opiate Enzyme Immunoassay	0021b	FDA UDI	Class II	Active
Ethyl Alcohol DAU Control, Level 2 Control	0225	FDA UDI	Class I	Active
Methadone Metabolite DAU Control, Level 1 Control	0197	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set E, Level 2 Control	0898	FDA UDI	Class I	Active
Multi-Analyte DAU Control Set E, Level 1 Control	0897	FDA UDI	Class I	Active
Norbuprenorphine DAU Control, Level 1 Control	A68824	FDA UDI	Class I	Active
Cannabinoids DAU Calibrator, Calibrator	0079c	FDA UDI	Class II	Active
Hydrocodone 100 DAU Calibrator, Cutoff Calibrator	0383	FDA UDI	Class II	Active
Oral Fluid Methamphetamine Enzyme Immunoassay	S0050b	FDA UDI	Class II	Active
Ecstasy DAU Control, Level 1 Control	0167	FDA UDI	Class I	Active
Barbiturate DAU Control, Control 4	0146	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

CEpartner4U NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

Lin-Zhi International, Inc. has 9 recall records initiated between August 5, 2011, and January 11, 2019, all of which are currently terminated. The reasons for these recalls include incorrect product labeling, manufacturing specifications not being met, decreased concentration or absorbance readings due to analyte degradation, and issues with quality control testing or shelf life.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.