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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 2 of 9

Device	Model / Reference	Registries	Class	Status
LZI Oxycodone 300 Intermediate Calibrator	0624	FDA UDI	Class II	Active
LZI Hydrocodone 300 Level 1 Control	C68828	FDA UDI	Class I	Active
6-Acetylmorphine DAU Calibrator, Intermediate Calibrator	0294	FDA UDI	Class II	Active
Amphetamines DAU Control, Level 2 Control	0048	FDA UDI	Class I	Active
Methadone Metabolite 300 DAU Calibrator, Low Calibrator	0192b	FDA UDI	Class II	Active
6-Acetylmorphine DAU Control, Level 2 Control	0298	FDA UDI	Class I	Active
LZI Methadone II Enzyme Immunoassay	0630	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set F, High Calibrator	0915	FDA UDI	Class II	Active
Hydrocodone 300 DAU Calibrator, Low Calibrator	0392	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set B, Cutoff Calibrator	0833	FDA UDI	Class II	Active
Oxycodone 100 DAU Control, Level 1 Control	0242b	FDA UDI	Class I	Active
Multi-Analyte DAU Calibrator Set E, High Calibrator	0895	FDA UDI	Class II	Active
Norbuprenorphine DAU Calibrator, Cutoff Calibrator	A68827	FDA UDI	Class II	Active
Oral Fluid 6-Acetylmorphine Calibrator, Intermediate Calibrator	S0294	FDA UDI	Class II	Active
Opiate 2000 DAU Calibrator, Cutoff Calibrator	0333	FDA UDI	Class II	Active
Amphetamines 500 DAU Control, Level 2 Control	0108	FDA UDI	Class I	Active
Oxycodone 100 DAU Control, Level 2 Control	0244b	FDA UDI	Class I	Active
Ecstasy DAU Control, Level 2 Control	0168	FDA UDI	Class I	Active
Methamphetamine DAU Calibrator, Intermediate Calibrator	0354	FDA UDI	Class II	Active
LZI Oxycodone 300 Level 1 Control	0627	FDA UDI	Class I	Active
Oxycodone DAU Calibrator, Low Calibrator	0252b	FDA UDI	Class II	Active
Norbuprenorphine DAU Calibrator, Intermediate Calibrator #1	0277	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set E, Intermediate Calibrator	0894	FDA UDI	Class II	Active
LZI Hydrocodone 300 Qualitative Calibrator	C68830	FDA UDI	Class II	Active
LZI Oxycodone 100 Level 1 Control	0617	FDA UDI	Class I	Active
Benzodiazepine Enzyme Immunoassay	0130	FDA UDI	Class II	Active
LZI Norfentanyl (Q) Qualitative Calibrator	C68815	FDA UDI	Class II	Active
Cannabinoids DAU Calibrator, Calibrator	0078c	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set C, Low Calibrator	0852	FDA UDI	Class II	Active
Propoxyphene DAU Calibrator, Low Calibrator	0122	FDA UDI	Class II	Active
Oral Fluid Methamphetamine Enzyme Immunoassay	S0051b	FDA UDI	Class II	Active
Methadone Metabolite 100 Control Set	08735620190	FDA UDI	Class I	Active
LZI Oxycodone 300 Cutoff Calibrator	0623	FDA UDI	Class II	Active
LZI Cotinine II Level 1 Control	0527	FDA UDI	Class I	Active
Norfentanyl DAU Control, Level 2 Control	0318	FDA UDI	Class I	Active
Methadone Metabolite Enzyme Immunoassay	0190	FDA UDI	N/A	Active
Cocaine Metabolite DAU Control, Level 2 Control	0038	FDA UDI	Class I	Active
Barbiturate DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3	0144	FDA UDI	Class I	Active
Opiate 2000 DAU Calibrator, Intermediate Calibrator	0334	FDA UDI	Class II	Active
Cocaine Metabolite DAU Calibrator, Cutoff Calibrator	0033	FDA UDI	Class II	Active
Amphetamines Enzyme Immunoassay	0040	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set C, Level 2 Control	0858	FDA UDI	Class I	Active
Carisprodol Metabolite (Meprobamate) DAU Calibrator, Cutoff Calibrator	0373	FDA UDI	Class II	Active
Cocaine Metabolite 150 DAU Control, Level 1 Control	0347	FDA UDI	Class I	Active
Norbuprenorphine DAU Calibrator, Intermediate Calibrator #2	0278	FDA UDI	Class II	Active
Methadone Metabolite 100 DAU Calibrator, Low Calibrator	0202b	FDA UDI	Class II	Active
Norbuprenorphine DAU Control, Level 2 Control	0276	FDA UDI	Class I	Active
Oral Fluid Methamphetamine Control, Level 1 Control	S0056b	FDA UDI	Class I	Active
Cocaine Metabolite 150 DAU Calibrator, Cutoff Calibrator	0343	FDA UDI	Class II	Active
Cannabinoids DAU Control, Control	0074c	FDA UDI	Class I	Active

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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.