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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

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 9 of 9

Device	Model / Reference	Registries	Class	Status
LZI Fentanyl III Enzyme Immunoassay	K251634	FDA 510(k)	Class II	Active
Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators And Controls	K050988	FDA 510(k)	Class I	Active
Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)	K033094	FDA 510(k)	Class II	Active
Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & Controls	K050945	FDA 510(k)	Class II	Active
Bmbp Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)	K033885	FDA 510(k)	Class II	Active
Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)	K020368	FDA 510(k)	Class II	Active
Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)	K032764	FDA 510(k)	Class II	Active
Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)	K033866	FDA 510(k)	Class II	Active
Multiple Analyte Urine Drugs Of Abuse Calibrators And Controls	K051088	FDA 510(k)	Class II	Active
Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls	K120761	FDA 510(k)	Class II	Active
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls	K141320	FDA 510(k)	Class II	Active
Methadone Enzyme Immunoassay	K023317	FDA 510(k)	Class II	Active
Single Analyte Urine Drugs Of Abuse Calibrators And Controls	K023316	FDA 510(k)	Class II	Active
Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators And Controls	K051058	FDA 510(k)	Class II	Active
Lzi Multiple Analyte Set A;b;c Drugs Of Abuse Controls	K133710	FDA 510(k)	Class II	Active
Fentanyl Control Set	10426667190	EUDAMEDFDA UDI	Class B	Active
6-Acetylmorphine Semi-Quantitative Calibrators Set	08240183190	EUDAMEDFDA UDI	Class B	Active
Fentanyl II Enzyme Immunoassay	10427531190	EUDAMED	Class B	Active
Ethyl Glucuronide 500 Control Set	09976515190	EUDAMED	Class B	Active
Buprenorphine Enzyme Immunoassay	08362955190	EUDAMEDFDA UDI	Class B	Active
Ethyl Glucuronide 500 Qualitative Calibrator Set	09976485190	EUDAMED	Class B	Active
Ethyl Glucuronide III Enzyme Immunoassay	09976523190	EUDAMED	Class B	Active
Ethyl Glucuronide 200 Qualitative Calibrator Set	09976477190	EUDAMED	Class B	Active
Ethyl Glucuronide 200 Control Set	09976507190	EUDAMED	Class B	Active
Fentanyl Qualitative Calibrator Set	09330097190	EUDAMEDFDA UDI	Class B	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.

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.