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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 7 of 9

Device	Model / Reference	Registries	Class	Status
Cannabinoids DAU Control, Control	0006c	FDA UDI	Class I	Active
Cocaine Metabolite DAU Calibrator, High Calibrator	0035	FDA UDI	Class II	Active
Methamphetamine DAU Calibrator, Low Calibrator	0352	FDA UDI	Class II	Active
Opiate DAU Control, Level 2 Control	0028	FDA UDI	Class I	Active
LZI Tramadol Cutoff Calibrator	0413	FDA UDI	Class II	Active
LZI Oxycodone III Enzyme Immunoassay	0610	FDA UDI	Class II	Active
Oral Fluid Cannabinoid Control, Level 2 Control	S0078c	FDA UDI	Class I	Active
Amphetamines DAU Calibrator, High Calibrator	0045	FDA UDI	Class II	Active
Hydrocodone 100 Enzyme Immunoassay	0380	FDA UDI	Class II	Active
Amphetamines 500 DAU Calibrator, High Calibrator	0105	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set D, Cutoff Calibrator	0873	FDA UDI	Class II	Active
Oral Fluid Amphetamine Enzyme Immunoassay	S0040b	FDA UDI	Class II	Active
6-Acetylmorphine DAU Control, Level 1 Control	0297	FDA UDI	Class I	Active
Multi-Analyte DAU Calibrator Set F, Intermediate Calibrator	0914	FDA UDI	Class II	Active
6-Acetylmorphine Enzyme Immunoassay	0291	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set F, Level 2 Control	0918	FDA UDI	Class I	Active
Buprenorphine Semi-Quantitative Calibrators Set	08239886190	FDA UDI	Class II	Active
Oral Fluid Amphetamine Calibrator, Cutoff Calibrator	S0043b	FDA UDI	Class II	Active
Cannabinoids DAU Calibrator, Calibrator	0072c	FDA UDI	Class II	Active
Methadone DAU Control, Level 1 Control	0117	FDA UDI	Class I	Active
Cocaine Metabolite 150 Enzyme Immunoassay	0340	FDA UDI	Class II	Active
Carisprodol Metabolite (Meprobamate) DAU Calibrator, Low Calibrator	0372	FDA UDI	Class II	Active
Hydrocodone 100 DAU Calibrator, Intermediate Calibrator	0384	FDA UDI	Class II	Active
Cocaine Metabolite 150 DAU Calibrator, Low Calibrator	0342	FDA UDI	Class II	Active
Opiate 2000 Enzyme Immunoassay	0331	FDA UDI	Class II	Active
Cannabinoid Enzyme Immunoassay	0071c	FDA UDI	Class II	Active
Oral Fluid Methamphetamine Calibrator, High Calibrator	S0055b	FDA UDI	Class II	Active
Hydrocodone 300 DAU Control, Level 1 Control	0397	FDA UDI	Class I	Active
Negative DAU Calibrator	0001	FDA UDI	Class II	Active
Cocaine Metabolite DAU Control, Level 1 Control	0037	FDA UDI	Class I	Active
Oral Fluid Amphetamine Control, Level 2 Control	S0047b	FDA UDI	Class I	Active
Multi-Analyte DAU Calibrator Set E, Low Calibrator	0892	FDA UDI	Class II	Active
Oral Fluid 6-Acetylmorphine Calibrator, Negative Calibrator	S0298	FDA UDI	Class II	Active
Hydrocodone 100 DAU Calibrator, High Calibrator	0385	FDA UDI	Class II	Active
Methadone Metabolite 100 Semi-Quantitative Calibrators Set	08735603190	FDA UDI	Class II	Active
Oral Fluid Cannabinoid Calibrator, High Calibrator	S0076c	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set C, Level 1 Control	0857	FDA UDI	Class I	Active
Methadone Metabolite 100 DAU Calibrator, Intermediate Calibrator	0204b	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set F, Low Calibrator	0912	FDA UDI	Class II	Active
Methamphetamine DAU Calibrator, High Calibrator	0355	FDA UDI	Class II	Active
Norbuprenorphine DAU Calibrator, Low/Cutoff Calibrator #1	0273	FDA UDI	Class II	Active
Methadone Metabolite DAU Calibrator, Low Calibrator	0192	FDA UDI	Class II	Active
Multi-Analyte DAU Control Set A, Level 2 Control	0818	FDA UDI	Class I	Active
Norbuprenorphine DAU Calibrator, Intermediate Calibrator #2	A68829	FDA UDI	Class II	Active
LZI Tramadol Level 2 Control	0418	FDA UDI	Class I	Active
Cannabinoids DAU Calibrator/Control, Calibrator/Control	0007c	FDA UDI	Class I	Active
Oxycodone DAU Calibrator, High Calibrator	0249b	FDA UDI	Class II	Active
Multi-Analyte DAU Calibrator Set B, Intermediate Calibrator	0834	FDA UDI	Class II	Active
LZI Cotinine II Cutoff Calibrator	0523	FDA UDI	Class II	Active
Methamphetamine DAU Calibrator, Cutoff Calibrator	0353	FDA UDI	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.