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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 8 of 9

Device	Model / Reference	Registries	Class	Status
Methadone Metabolite 300 DAU Calibrator, Cutoff Calibrator	0193b	FDA UDI	Class II	Active
Oxycodone 300 DAU Control, Level 2 Control	0247b	FDA UDI	Class I	Active
Multi-Analyte DAU Control Set B, Level 1 Control	0837	FDA UDI	Class I	Active
Hydrocodone 100 Control Set	08304742190	FDA UDI	Class I	Active
Opiate DAU Calibrator, Intermediate Calibrator	0024	FDA UDI	Class II	Active
Hydrocodone 100 DAU Control, Level 1 Control	0387	FDA UDI	Class I	Active
Hydrocodone 300 DAU Calibrator, Intermediate Calibrator	0394	FDA UDI	Class II	Active
Methadone Metabolite 100 DAU Control, Level 2 Control	0208b	FDA UDI	Class I	Active
Ecstasy DAU Calibrator, Cutoff Calibrator	0163	FDA UDI	Class II	Active
Ecstasy DAU Calibrator, Low Calibrator	0162	FDA UDI	Class II	Active
Methadone Metabolite DAU Calibrator, High Calibrator	0195	FDA UDI	Class II	Active
Opiate 2000 DAU Control, Level 2 Control	0338	FDA UDI	Class I	Active
LZI Oxycodone 100 Intermediate Calibrator	0614	FDA UDI	Class II	Active
Ethyl Glucuronide 200 Semi-Quantitative Calibrators Set	09976493190	EUDAMED	Class B	Active
Ethyl Glucuronide 500 Semi-Quantitative Calibrators Set	09976558190	EUDAMED	Class B	Active
Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls	K120763	FDA 510(k)	Class II	Active
Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit)	K020395	FDA 510(k)	Class II	Active
Opiate Enzyme Immunoassay	K110298	FDA 510(k)	Class II	Active
Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221	K032461	FDA 510(k)	Class II	Active
Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators And Controls	K063024	FDA 510(k)	Class II	Active
Oxycodone Enzyme Immunoassay And Oxycodone Calibrators And Controls	K050733	FDA 510(k)	Class II	Active
Buprenorphine Enzyme Immunoassay With Norbuprenorphine Calibrators And Controls	K090844	FDA 510(k)	Class II	Active
LZI Fentanyl II Enzyme Immunoassay	K201938	FDA 510(k)	Class II	Active
Benzodiazepine Enzyme Immunoassay	K032365	FDA 510(k)	Class II	Active
Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls	K131653	FDA 510(k)	Class II	Active
Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071	K021887	FDA 510(k)	Class II	Active
Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011	K020254	FDA 510(k)	U	Active
Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators And Controls	K062242	FDA 510(k)	Class II	Active
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay	DEN170010	FDA 510(k)	Class II	Active
Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls	K131652	FDA 510(k)	Class II	Active
Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ml), (15ml); Controls; (5ml), (15ml)	K141055	FDA 510(k)	Class II	Active
Lzi Cannabinoids (cthc) Homogeneous Enzyme Immunoassay, Calibrators, Control	K110239	FDA 510(k)	Class II	Active
Single Analyte Urine Drugs Of Abuse Calibrators And Controls	K020769	FDA 510(k)	Class II	Active
LZI Oxycodone III Enzyme Immunoassay	K202007	FDA 510(k)	Class II	Active
Cannabinoid Urine Drugs Of Abuse Calibrators And Controls	K021449	FDA 510(k)	Class II	Active
LZI Buprenorphine II Enzyme Immunoassay	K253082	FDA 510(k)	Class II	Active
LZI Cotinine II Enzyme Immunoassay	K192299	FDA 510(k)	Class I	Active
Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay, Calibrators, Controls	K113139	FDA 510(k)	Class II	Active
Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls	K102210	FDA 510(k)	Class II	Active
Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-Acetylmorphine Calibrators (5 Ml), Lzi Oral Fluid 6	K141205	FDA 510(k)	Class II	Active
Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls	K113661	FDA 510(k)	Class II	Active
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators	K170416	FDA 510(k)	Class II	Active
Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)	K023795	FDA 510(k)	Class II	Active
Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)	K020763	FDA 510(k)	Class II	Active
Buprenorphine Enzyme Immunoassay, Calibrators And Controls For Beckman Coulter Synchron Systems	K081008	FDA 510(k)	Class II	Active
LZI Tramadol Enzyme Immunoassay	K201223	FDA 510(k)	Class II	Active
6-Acetylmorphine Enzyme Immunoassay With 6-Acetylmorphine Calibrators And Controls	K101195	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Methadone Metabolite (eddp) Enzime Immunoassay, Cat. No. 190 (500 Test Kit), No. 191 (5000 Test Kit)	K031797	FDA 510(k)	Class II	Active
LZI Methadone II Enzyme Immunoassay	K192433	FDA 510(k)	Class II	Active
LZI Fentanyl Enzyme Immunoassay	K181159	FDA 510(k)	Class II	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.