Immundiagnostik Inc

FDA Filings

This page includes the latest FDA filings for Immundiagnostik Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Immundiagnostik Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3015189693
FEI Number3015189693
NameIMMUNDIAGNOSTIK, INC.
Owner & OperatorImmundiagnostik, Inc.
Contact Address400 BEDFORD ST Suite 104
Manchester NH 03101 US
Official Correspondent
  • Terance Fisher
  • 1-888-4339020-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address400 BEDFORD ST Suite 104
Manchester, NH 03101 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
IMMUNDIAGNOSTIK, INC.
ox-LDL/MDA Adduct ELISA2018-12-18
IMMUNDIAGNOSTIK, INC.
Lysozyme ELISA2018-12-18
IMMUNDIAGNOSTIK, INC.
IDK? Hemoglobin ELISA2018-12-18
IMMUNDIAGNOSTIK, INC.
IDK? sIgA2018-12-18
IMMUNDIAGNOSTIK, INC.
IDK Extract?2018-11-30
IMMUNDIAGNOSTIK, INC.
IDK? Pancreatic Elastase ELISA2018-11-30

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