MedtechSourcebook

DIASORIN INC.

Contract manufacturer ยท Stillwater, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2013Product codes first listed, by year (tallest: 7)2026
FDA registration
2182595 (openFDA record; or search FDA's registration database)
FEI number
2182595
Registered for
FDA registration year 2027
Establishment types
Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
DiaSorin Inc. (FDA owner/operator no. 9051149)
Registered address
1951 Northwestern Ave, Stillwater, MN 55082
Contract listings
6 device listings, 8 product codes, first listed Jan 4, 2013
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DCFAlbumin, Antigen, Antiserum, ControlClass IIImmunologyContract manufacturingJan 4, 2013
DDGTransferrin, Antigen, Antiserum, ControlClass IIImmunologyContract manufacturingJan 4, 2013
JITCalibrator, SecondaryClass IIClinical chemistryContract manufacturingJan 4, 2013
JIXCalibrator, Multi-Analyte MixtureClass IIClinical chemistryContract manufacturingJan 4, 2013
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Class IClinical chemistryContract manufacturingJan 4, 2013
JJYMulti-Analyte Controls, All Kinds (Assayed)Class IClinical chemistryContract manufacturingJan 4, 2013
MSJApolipoproteinsClass IClinical chemistryContract manufacturingJan 4, 2013
NCDTest, Immunity, Cell Mediated, Mycobacterium TuberculosisClass IIIMicrobiologyContract manufacturingDec 1, 2019