Data / Medical devices / China / Eterbio, Inc.

Eterbio, Inc.: FDA-registered device maker in Zhuhai Guangdong, China, 6 510(k) clearances

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

Eterbio, Inc. is registered with the FDA (registration 3032147516) in Zhuhai Guangdong, China. It lists 29 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 20, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3032147516
Address: Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China, Zhuhai Guangdong, China, 519000
Owner or operator: Eterbio, Inc. (10091094)
Roles: Exporter to the US, Manufacturer
First device listed: June 30, 2024
Registered through: 2026
Brand names listed: ETERBIO Fentanyl/Norfentanyl Home Test, ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold), Famwell Fentanyl/Norfentanyl Home Test, Famwell Fentanyl/Norfentanyl Rapid Test (Colloidal Gold), O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold), O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust MAX Multi-Drug Test Cup Rx(Colloidal Gold) and more

Devices it lists

Device	Product code	Class	Role	Source
Calibrators, Ethyl Alcohol	DNN	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Exporter to the US, Manufacturer	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	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Exporter to the US, Manufacturer	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	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	Manufacturer	accessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, Exempt	PVG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	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 Antidepressant Drugs, Employment And Insurance Testing, Exempt	PVK	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	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
November 20, 2024	K243064	ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test	NGL	Substantially Equivalent	Eterbio, Inc.	accessdata.fda.gov
March 31, 2023	K230238	BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx	DJG	Substantially Equivalent	Shenzhen Bioeasy Biotechnology Co., Ltd.	accessdata.fda.gov
January 31, 2020	K193480	BIOEASY Multi-Drug Test Cup	NGL	Substantially Equivalent	Shenzhen Bioeasy Biotechnology Co., Ltd.	accessdata.fda.gov
October 11, 2019	K192515	BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20	LDJ	Substantially Equivalent	Shenzhen Bioeasy Biotechnology Co., Ltd.	accessdata.fda.gov
September 20, 2019	K192301	BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip	NFW	Substantially Equivalent	Shenzhen Bioeasy Biotechnology Co., Ltd.	accessdata.fda.gov
November 9, 2018	K182530	BIOEASY Multi-Drug Test Cup	NFT	Substantially Equivalent	Shenzhen Bioeasy Biotechnology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 20, 2024. 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.