Data / Medical devices / United States / Advin Biotech, Inc.

Advin Biotech, Inc.: FDA-registered device maker in San Diego, CA, United States, 4 510(k) clearances

Name: Advin Biotech, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Advin Biotech, Inc. is registered with the FDA (registration 3010934853) in San Diego, CA, United States. It lists 39 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010934853
Address: 10140 Mesa Rim Rd., Unit 1, San Diego, CA, United States, 92121
Owner or operator: Advin Biotech Inc (10046939)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: June 3, 2014
Registered through: 2027
Brand names listed: ALOFT Cotinine, ATTEST, ATTEST DRUG TEST, ATTEST Drug Screen Cup & DIP Card, ATTEST Drug Test, Advin COVID-19 Antigen Test @Home, Advin Multi Drug Screen Test, Advin Multi-Drug Screen Test Cassette/Cup/Dip Card and more

Devices it lists

Device	Product code	Class	Role	Source
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Nicotine And Nicotine Metabolites	MKU	1	Contract manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Contract manufacturer	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, Exempt	PUX	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, Exempt	PUY	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Contract manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Manufacturer	accessdata.fda.gov
Test, Codeine, Employment And Insurance Testing, Exempt	PVB	2	Manufacturer	accessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, Exempt	PVE	2	Contract manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, Exempt	PVF	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, Exempt	PVG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Manufacturer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Manufacturer	accessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, Exempt	PVI	2	Manufacturer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 9, 2025	K252867	VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup	NFT	Substantially Equivalent	Advin Biotech, Inc.	accessdata.fda.gov
September 17, 2020	K201494	ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card	DJG	Substantially Equivalent	Advin Biotech, Inc.	accessdata.fda.gov
March 29, 2019	K182123	ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card	DJG	Substantially Equivalent	Advin Biotech, Inc.	accessdata.fda.gov
June 17, 2013	K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	DKZ	Substantially Equivalent	Advin Biotech	accessdata.fda.gov

Compare with other makers

Updated October 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.