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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 3 of 9

Device	Model / Reference	Registries	Class	Status
Multi-Analyte DAU Calibrator Set F, Cutoff Calibrator	0913	FDA UDI	Class II	Active
Hydrocodone 300 Enzyme Immunoassay	0390	FDA UDI	Class II	Active
Ecstasy DAU Calibrator, Intermediate Calibrator	0164	FDA UDI	Class II	Active
Methadone Metabolite 100 Qualitative Calibrator Set	08735590190	FDA UDI	Class II	Active
6-Acetylmorphine Enzyme Immunoassay	0290	FDA UDI	Class II	Active
Benzodiazepine DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3	0134	FDA UDI	Class I	Active
LZI Hydrocodone 100 Qualitative Calibrator	C68824	FDA UDI	Class II	Active
Cannabinoids DAU Calibrator/Control, Calibrator/Control	0076c	FDA UDI	Class I	Active
Oral Fluid Methamphetamine Control, Level 2 Control	S0057b	FDA UDI	Class I	Active
Oral Fluid 6-Acetylmorphine Enzyme Immunoassay	S0291	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set D, High Calibrator	0875	FDA UDI	Class II	Active
Oral Fluid Cannabinoid Calibrator, Cutoff Calibrator	S0074c	FDA UDI	Class II	Active
Opiate Enzyme Immunoassay	0020b	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set C, Cutoff Calibrator	0853	FDA UDI	Class II	Active
Methadone Metabolite Enzyme Immunoassay	0191b	FDA UDI	Class II	Active
Propoxyphene DAU Control, Level 1 Control	0127	FDA UDI	Class I	Active
Cocaine Metabolite Enzyme Immunoassay	0030	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set D, Level 1 Control	0877	FDA UDI	Class I	Active
LZI Oxycodone 300 Level 2 Control	0628	FDA UDI	Class I	Active
Multi-Analyte DAU Calibrator Set A, Low Calibrator	0812	FDA UDI	Class II	Active
LZI Tramadol Low Calibrator	0412	FDA UDI	Class II	Active
Oral Fluid 6-Acetylmorphine Calibrator, High Calibrator	S0295	FDA UDI	Class II	Active
LZI Tramadol Level 1 Control	0417	FDA UDI	Class I	Active
LZI Hydrocodone 300 Level 2 Control	C68829	FDA UDI	Class I	Active
Buprenorphine Enzyme Immunoassay	09067752190	FDA UDI	Class II	Active
Opiate DAU Calibrator, Cutoff Calibrator	0023	FDA UDI	Class II	Active
Methadone Metabolite 300 Control Set	08735689190	FDA UDI	Class I	Active
Methadone Enzyme Immunoassay	0110	FDA UDI	Class II	Active
Ecstasy Enzyme Immunoassay	0161	FDA UDI	Class II	Active
Methadone Metabolite Enzyme Immunoassay	08735581190	FDA UDI	Class II	Active
Propoxyphene Enzyme Immunoassay	0121	FDA UDI	Class II	Active
Hydrocodone 300 Enzyme Immunoassay	0391	FDA UDI	Class II	Active
Methamphetamine DAU Control, Level 1 Control	0357	FDA UDI	Class I	Active
Hydrocodone 100 Enzyme Immunoassay	0381	FDA UDI	Class II	Active
Methadone Metabolite Enzyme Immunoassay	0191	FDA UDI	Class II	Active
Norbuprenorphine DAU Control, Level 1 Control	0272	FDA UDI	Class I	Active
Amphetamines DAU Calibrator, Intermediate Calibrator	0044	FDA UDI	Class II	Active
Ethyl Alcohol Enzymatic Assay	0220	FDA UDI	Class II	Active
Methadone Metabolite DAU Calibrator, Cutoff Calibrator	0193	FDA UDI	Class II	Active
Barbiturate DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2	0143	FDA UDI	Class I	Active
Amphetamines 500 Enzyme Immunoassay	0100	FDA UDI	Class II	Active
Cocaine Metabolite 150 DAU Calibrator, High Calibrator	0345	FDA UDI	Class II	Active
LZI Cotinine II Enzyme Immunoassay	0521	FDA UDI	Class I	Active
Phencyclidine Enzyme Immunoassay	0011	FDA UDI	U	Active
Fentanyl II Enzyme Immunoassay	09310002190	FDA UDI	Class II	Active
Opiate DAU Calibrator, High Calibrator	0025	FDA UDI	Class II	Active
Propoxyphene DAU Calibrator, Cutoff Calibrator	0123	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set D, Level 2 Control	0878	FDA UDI	Class I	Active
LZI Oxycodone 300 Low Calibrator	0622	FDA UDI	Class II	Active
Oral Fluid 6-Acetylmorphine Control, Level 2 Control	S0297	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.

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.