Phadia Us Inc

FDA Filings

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

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

FDA Registration(s)
Registration Number3004973408
FEI Number3004973408
NamePHADIA US INC.
Owner & OperatorPHADIA AB
Contact AddressRapsgatan 7P P.O. Box 6460
UPPSALA SE-C Uppsala lan [SE-03] 75137 SE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4169 COMMERCIAL AVE.
Portage, MI 49002 US



FDA Filings

Device
Company
DeviceDate
PHADIA US INC.
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 2502015-02-13
PHADIA US INC.
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO2014-10-27
PHADIA US INC.
EIA SMDP IMMUNOASSAY2014-08-29
PHADIA US INC.
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY2013-12-23
PHADIA US INC.
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES2013-08-28
PHADIA US INC.
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE2012-09-13
PHADIA US INC.
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY2012-06-22
PHADIA US INC.
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE2012-02-15
PHADIA US INC.
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS2011-12-22
PHADIA US INC.
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM2011-09-30
PHADIA US INC.
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-012010-08-13
PHADIA US INC.
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM2010-06-07
PHADIA US INC.
IMMUNOCAP RAPID READER, MODEL 12-3600-102010-01-19
PHADIA US INC.
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-012009-05-28
PHADIA US INC.
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY2009-04-10
PHADIA US INC.
VARELISA RECOMBI ANA SCREEN, MODEL 12 5962009-03-13
PHADIA US INC.
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-012008-01-15
PHADIA US INC.
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-012007-12-07
PHADIA US INC.
IMMUNOCAP THYRLOBULIN IMMUNOCAP2007-11-20
PHADIA US INC.
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL2007-03-14
PHADIA US INC.
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-012006-12-29
PHADIA US INC.
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-012006-12-26

Related Finance Registrations
CAGE Code1QNW5PHADIA US INC. IMMUNODIAGNOSTICS
S.A.M. Registration1QNW5 [145061557]PHADIA US INC.

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