Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008096179

FEI Number

3008096179

Entity Name

Immudex, Aps

City/State/Country

Virum Hovedstaden, DK

Establishment Address

Bredevej 2A, Virum Hovedstaden DK-2830, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Immudex (Owner Number: 10033288)

Owner / Operator Contact Address

Bredevej 2A, Virum, DK-84 2830, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153538

PMA Number

N/A

All Registered Proprietary Names

MHC Dextramer U-Load Dextramer CD1d Monomer MR1 Monomer Klickmer MHC Monomer MR1 Dextramer U-Load dCODE Dextramer HLA-G Monomer dCODE Dextramer HLA-G Dextramer CAR Dextramer dCODE Klickmer Xynapse-T CD1d Dextramer CMV Dextramer MHC Dextramer Dextramer® CMV Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTU	Research Use Only/Pathology	Unknown	Class N	N/A	2012-06-19
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2013-12-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2017-10-25

Official Correspondent

Liselotte Brix

US Agent Details

Alessandra Audia Business: IMMUDEX USA, LLC Email: ale@immudex.com Phone: (713) 7057161

Related Public Records

Same Entity

Immudex

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
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

Registration Number	Establishment Name	Location
3013380116	JETA MOLECULAR B.V.	Utrecht, NL
3013540184	XIAMEN ZEESAN BIOTECH CO., LTD	Xiamen Fujian, CN
3003423869	Agilent Technologies Singapore (International) Pte Ltd.	Singapore North East, SG
3004765453	KASHMIR SURGICAL WORKS	AMBALA Haryana, IN
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008096179. Last updated year: 2026. Please use registration number 3008096179 when referencing this establishment in official correspondence.