Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016587486

FEI Number

3016587486

Entity Name

ARX SCIENCES

City/State/Country

Amherst, NY, US

Establishment Address

160 Lawrence Bell Drive, Suite 120, Amherst, NY 14221, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARX Sciences (Owner Number: 10063137)

Owner / Operator Contact Address

160 Lawrence Bell Drive, Suite 120, Amherst, NY 14221, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARX Liquid Amies Collection & Transport System ARX Viral Transport Media Collection and Transport System (ARX-VTM) ARX Sterile Buffered Saline ARX Aspergillus galactomannan antigen (GalMAg) EIA & Lateral Flow Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2024-08-06
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2024-08-06
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2024-08-06
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2024-08-06
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2022-02-16
JWT	Antigen, Cf, Aspergillus Spp.	Microbiology	Class 1	866.3040	2022-07-25

Official Correspondent

Chad Werts

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARX Sciences

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
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

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8022032	SOUTHMEDIC, INC.	BARRIE Ontario, CA
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
2024800	Hologic, Inc.	SAN DIEGO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016587486. Last updated year: 2026. Please use registration number 3016587486 when referencing this establishment in official correspondence.