ROSSIX AB

FDA Device Registration & Listing · Molndal Vastra Gotaland, SE · Registration 3004075036

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004075036
FEI Number
3004075036
Entity Name
ROSSIX AB
City/State/Country
Molndal Vastra Gotaland, SE
Establishment Address
Taljegardsgatan 3B, Molndal Vastra Gotaland 43153, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Rossix AB (Owner Number: 10090697)
Owner / Operator Contact Address
Taljegardsgatan 3B, Molndal, SE-O 43153, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230852
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2024-04-30

Official Correspondent

Pia Bryngelhed

US Agent Details

Carol Marble Business: Instrumentation Laboratory Company Email: cmarble@werfen.com Phone: (781) 8614467

Related Public Records

Same Entity

Rossix AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K972288 Universal Reagents, Inc. FACTOR DEFICIENT PLASMAS - FACTOR IX (9) 1997-07-14
K010379 Instrumentation Laboratory CO IL TEST FREE PROTEIN S 2001-04-13
K033631 Instrumentation Laboratory CO MODIFICATION TO COATEST FACTOR VIII 2003-12-15
K924884 Instrumentation Laboratory CO IL TEST(TM) PRO-CHROM 1993-01-14
K042576 Instrumentation Laboratory CO COATEST SP FVIII 2004-12-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0736-2016 Instrumentation Laboratory Co. 2
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012 Instrumentation Laboratory Co. 2
Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

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1217183 INSTRUMENTATION LABORATORY CO. Bedford, MA, US
2245451 DIAGNOSTICA STAGO, INC. PARSIPPANY, NJ, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004075036. Last updated year: 2026. Please use registration number 3004075036 when referencing this establishment in official correspondence.
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