FDA Registration
Active
🇺🇸 United States
ARX SCIENCES
Reg #: 3016587486
·
FEI: 3016587486
·
Expires 2026
Products
7
Proprietary Names
5
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ARX SCIENCES
- Registration Number
- 3016587486
- FEI Number
- 3016587486
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 160 Lawrence Bell Drive, Suite 120
- City
- Amherst
- State
- NY
- ZIP
- 14221
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222613
Owner / Operator
- Firm Name
- ARX Sciences
- Operator Number
- 10063137
- Address
- 160 Lawrence Bell Drive, Suite 120
- City
- Amherst
- State
- NY
- Postal Code
- 14221
- Country
- US
- Correspondent
- Chad M Werts
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2024-08-06 |
| Transport Systems, Anaerobic | JTX | Class 1 | Microbiology | No | 2024-08-06 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2024-08-06 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2024-08-06 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2022-02-16 |
| Antigen, Cf, Aspergillus Spp. | JWT | Class 1 | Microbiology | No | 2022-07-25 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2024-11-21 |
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
ARX Swabs: Nasopharyngeal & Tapered Tip 100 & 80mm breakpoint; Oropharyngeal 100 & 80 & 30mm breakpoint ;Anterior Nares
Establishment Types
Manufacture Medical Device