FDA Device Establishments · JSON-LD · Markdown

DIAGENODE s.a.

FEI 3010534606 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3010534606
Owner / OperatorDiagenode s.a. (#10079757)
AddressRue du Bois Saint Jean 3, Seraing Liege, 4102, BE
Mandatory US AgentHologic Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)JJX
Regulation § (21 CFR)862.1660
Proprietary namesMycoplasma genitalium Macrolide Resistance IVT A2058G Control; Mycoplasma genitalium Macrolide Resistance IVT A2059C Control; Mycoplasma genitalium Macrolide Resistance IVT A2059G Control; Mycoplasma genitalium Macrolide Resistance IVT A2058C Control; Mycoplasma genitalium Macrolide Resistance IVT A2058T Control; Mycoplasma genitalium IVT WT Control

External sources

Source: openFDA. Public-domain (CC0).