BOSTON EASY BIOTECH INC

FDA Device Registration & Listing · Andover, MA, US · Registration 3024753119

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024753119
FEI Number
3024753119
Entity Name
BOSTON EASY BIOTECH INC
City/State/Country
Andover, MA, US
Establishment Address
200 Brickstone Square, Suite 104, Andover, MA 01810, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device
Owner / Operator
Boston Easy Biotech Inc (Owner Number: 10086310)
Owner / Operator Contact Address
200 Brickstone Square, Suite 104, Andover, MA 01810, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K250398
PMA Number
N/A

All Registered Proprietary Names

BEB Plasmodium spp. Detection Test Famwell Digital Pregnancy Rapid Test BEB H. pylori Rapid Test BEB Toxo Igg Li BEB OCCULT BLOOD Test BEB Urine Drug Rapid Tests Influenza Combo Test BEB dengue igm and igg antibodies test BEB Fentanyl Rapid Tests Famwell Flu A/B Antigen Rapid Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OAX Plasmodium Spp. Detection Reagents Microbiology Class 2 866.3402 2023-03-06
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-02-01
OWF Immunohistochemical Assay, Helicobacter Pylori Microbiology Class 1 866.3110 2023-03-06
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2023-03-06
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2023-03-06
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2023-06-06
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2026-03-06
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2026-03-06
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2026-03-06
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2026-03-06
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2026-03-06
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2026-03-06
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2026-03-06
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2026-03-06
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2026-03-06
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2026-03-06
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2026-03-06
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2026-03-06
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2022-10-29
NWY Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies Unknown Class N N/A 2023-03-06
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2026-03-06
PSZ Devices Detecting Influenza A, B, And C Virus Antigens Microbiology Class 2 866.3328 2025-07-10

Official Correspondent

ZHI Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Easy Biotech Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
Z-0038-2020 Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands 1
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024753119. Last updated year: 2026. Please use registration number 3024753119 when referencing this establishment in official correspondence.
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