Data / Medical devices / United States / Boston Easy Biotech Inc

Boston Easy Biotech Inc: FDA-registered device maker in Belmont, MA, United States, 6 510(k) clearances

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

Boston Easy Biotech Inc is registered with the FDA (registration 3024753119) in Belmont, MA, United States. It lists 25 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3024753119
Address: 375 Concord Ave Ste 202-B, Belmont, MA, United States, 02478
Owner or operator: Boston Easy Biotech Inc (10086310)
Roles: Complaint file establishment, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: October 29, 2022
Registered through: 2026
Brand names listed: BEB Dengue virus antigen Test, BEB Fentanyl Rapid Tests, BEB H. pylori Antigen Rapid Test, BEB H. pylori Rapid Test, BEB LH Ovulation Rapid Test Strip, BEB Multi-Drug Rapit Test, BEB Multi-Drug Test Kit, BEB OCCULT BLOOD Test and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry, Micro, For Clinical Use	JJF	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Dengue Virus Antigen Assay	QCU	2	Manufacturer for export	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Manufacturer for export, Repackager or relabeler, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer for export	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer for export	accessdata.fda.gov
Immunohistochemical Assay, Helicobacter Pylori	OWF	1	Manufacturer for export	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Plasmodium Spp. Detection Reagents	OAX	2	Manufacturer for export	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Manufacturer for export	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Specification developer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Specification developer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Specification developer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Specification developer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Specification developer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Specification developer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Specification developer	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	2	Specification developer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Specification developer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Specification developer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Specification developer	accessdata.fda.gov
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies	NWY	N	Manufacturer for export	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Specification developer	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
July 3, 2025	K250398	Innovita Flu A/B Antigen Rapid Test	PSZ	Substantially Equivalent	Innovita (Tangshan) Biological Technology Co., Ltd.	accessdata.fda.gov
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
November 30, 2022	K222305	MissLan Digital Pregnancy Rapid Test	LCX	Substantially Equivalent	Guangzhou Decheng Biotechnology Co., Ltd.	accessdata.fda.gov
November 22, 2019	K192843	INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream	LCX	Substantially Equivalent	Innovita (Tangshan) Biological Technology 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 July 3, 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.