Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680745

FEI Number

3005774014

Entity Name

PHADIA GMBH

City/State/Country

FREIBURG Baden-Wurttemberg, DE

Establishment Address

MUNZINGER STRASSE 7, FREIBURG Baden-Wurttemberg D-79111, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PHADIA AB (Owner Number: 9004441)

Owner / Operator Contact Address

Rapsgatan 7P, P.O. Box 6460, UPPSALA, SE-C 75137, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EliA Ro52 EliA Ro60 EliA Gliadin DP IgA Well EliA Gliadin DP IgG Well ELIA CELIKEY IGG WELL Phadia 250 and Phadia 2500, Phadia 5000 Instrument E series EliA RNA Pol III EliA Stool Extraction Kit plus Phadia 250 and Phadia 2500, Phadia 5000 Instrument E series EliA Rib-P EliA Cardiolipin IgA Immunoassay EliA Scl-70S Immunoassay EliA SymphonyS Phadia 2500E, Phadia 2500EE, Phadia 5000E, and Phadia 5000E+E EliA Jo-1 EliA RNP70 EliA ß2-Glycoprotein I IgA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2022-09-07
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2010-08-16
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2007-04-11
NYO	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody	Immunology	Class 2	866.5100	2021-09-14
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2026-02-06
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2021-09-14
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-12-27
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2013-12-27
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2014-11-04
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2019-12-10
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	Class 2	866.5100	2009-06-04
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2009-06-04
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2012-06-29

Official Correspondent

No official correspondent registered.

US Agent Details

Carla Krause Business: Phadia US Inc. Email: carla.krause@thermofisher.com Phone: (616) 2864138

Related Public Records

Same Entity

PHADIA AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3039353646	PHADIA AB	Uppsala, SE
9610566	PHADIA AB	UPPSALA, SE
3004973408	PHADIA US INC.	Portage, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K091556	Instrumentation Laboratory CO	HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS	2010-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680745. Last updated year: 2026. Please use registration number 9680745 when referencing this establishment in official correspondence.