Data / Medical devices / United States / Arx Sciences
Arx Sciences: FDA-registered device maker in Amherst, NY, United States, 2 510(k) clearances
Arx Sciences is registered with the FDA (registration 3016587486) in Amherst, NY, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016587486
- Address
- 160 Lawrence Bell Drive Suite 120, Amherst, NY, United States, 14221
- Owner or operator
- ARX Sciences (10063137)
- Roles
- Manufacturer
- First device listed
- February 16, 2022
- Registered through
- 2026
- Brand names listed
- ARX Aspergillus galactomannan antigen (GalMAg) EIA & Lateral Flow Assay, ARX Liquid Amies Collection & Transport System, ARX Sterile Buffered Saline, ARX Swabs: Nasopharyngeal & Tapered Tip 100 & 80mm breakpoint; Oropharyngeal 100 & 80 & 30mm breakpoint ;Anterior Nares, ARX Viral Transport Media Collection and Transport System (ARX-VTM)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Cf, Aspergillus Spp. | JWT | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Manufacturer | accessdata.fda.gov |
| System, Transport, Aerobic | JTW | 1 | Manufacturer | accessdata.fda.gov |
| Transport Systems, Anaerobic | JTX | 1 | 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 |
|---|---|---|---|---|---|---|
| March 27, 2024 | K222613 | ARX Liquid Amies Collection & Transport System | LIO | Substantially Equivalent | Arx Sciences, Inc. | accessdata.fda.gov |
| March 19, 2024 | K231843 | ARX Viral Transport Media Collection and Transport System | JSM | Substantially Equivalent | Arx Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Non-Propagating Transport
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Device, Specimen Collection
- All makers of Transport Systems, Anaerobic
- All makers of System, Transport, Aerobic
Updated March 27, 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.