FDA Device Establishments · JSON-LD · Markdown
FEI 3007652384 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3007652384 |
|---|---|
| Owner / Operator | Microbix (#10061165) |
| Address | 265 Watline Avenue, Mississauga Ontario, L4Z 1P3, CA |
| Mandatory US Agent | Icon Clinical Research |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | JJX |
| Regulation § (21 CFR) | 862.1660 |
| Proprietary names | REDx Shiga toxin-producing E. coli Positive Control; REDxFLOQ® Trichomonas vaginalis Swab Positive Control; REDxFLOQ® HPV 31/33/66 Swab Positive Control; REDx Clostridium difficile Positive Control; REDxFLOQ® HPV 45 Swab Positive Control; REDxFLOQ® Chlamydia trachomatis & Neisseria gonorrhoeae Swab Positive Control; REDxFLOQ® Norovirus GI Ag Swab Positive Control; REDxFLOQ® Vibrio parahaemolyticus Swab Positive Control; REDxFLOQ® HPV 18 Swab Positive Control; REDxFLOQ® Adenovirus F40/41 Swab Positive Control |
Source: openFDA. Public-domain (CC0).