# SPEEDX PTY LTD

FEI: 3012113276
Status: Active
Establishment types: Export Device to the United States But Perform No Other Operation on Device; Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Owner/operator: SpeeDx Pty Ltd (#10057454)

Address: Suite 102, National Innovation Centre, 4 Cornwallis Street, Eveleigh New South Wales, 2015, AU

Mandatory US Agent: SpeeDx Inc.

## Products

Total registered: 1
Top product codes: JJX
Regulation §: 862.1660

Proprietary names: ResistancePlus GC Control, Positive Control Flu/RSV/SARS, ResistancePlus MG Positive Control, Positive Control HSV/VZV/TP

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223012113276%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3012113276