Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003825930

FEI Number

3003825930

Entity Name

AESKU.DIAGNOSTICS GmbH&Co.KG

City/State/Country

WENDELSHEIM Rhineland-Palatinate, DE

Establishment Address

MIKROFORUM RING 2, WENDELSHEIM Rhineland-Palatinate 55234, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aesku.Diagnostics GmbH & Co. KG (Owner Number: 9057973)

Owner / Operator Contact Address

MIKROFORUM RING 2, --, WENDELSHEIM, DE-RP 55234, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042644

PMA Number

N/A

All Registered Proprietary Names

HERA (HER-1000) AESKUSLIDES® ANCA AESKULISA® PR3 AESKULISA dsDNA G AESKUSLIDES® nDNA (Crithidia luciliae) AESKULISA® snRNP-C AESKULISA® Cenp-B AESKULISA® Jo-1 AESKULISA® Sm AESKULISA® SS-B AESKULISA® ANA-8Pro AESKULISA® SS-A AESKULISA® ENA-6Pro AESKULISA® Scl-70 AESKULISA® U1-70 AESKULISA ANA HEp-2 AESQC® ANA HEp-2 Nucleolar AESQC® ANA HEp-2 Cytoplasmic AESQC® ANA HEp-2 Homogeneous AESQC® ANA HEp-2 Speckled AESQC® Pool 1 AESQC® ANA HEp-2 Panel 1 AESQC® ANA HEp-2 Centromere AESQC® Pool 5 AESQC® Pool 3 AESQC® IFA Negative Control AESQC® Pool 4 AESQC® Pool 2 AESQC® Pool Mix AESKULISA® ASCA LED's HELMED® AUTOMATED IFA PROCESSOR (HEL-1000) AESKULISA® DGP AESKULISA® Cardiolipin AESKULISA® Glia AESKUSLIDES ® ANA HEp-2-Gamma HELIOS® AUTOMATED IFA SYSTEM (IOS-1000) AESKULISA® MPO AESKULISA® tTg New Gen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2022-01-21
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2018-05-04
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2010-06-11
LSW	Anti-Dna Antibody, Antigen And Control	Immunology	Class 2	866.5100	2026-04-23
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2018-05-04
LSW	Anti-Dna Antibody, Antigen And Control	Immunology	Class 2	866.5100	2018-05-04
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2003-10-09
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2003-10-09
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2026-04-23
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2009-12-11
NBT	Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)	Immunology	Class 2	866.5785	2006-04-24
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2011-07-15
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2008-01-22
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2013-12-16
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2004-03-09
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2006-04-24
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2018-05-14
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2018-05-14
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2010-06-09
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2006-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Nadine Shabat Business: Bion Enterprises, Ltd. Email: nadine.shabat@aesku-bion.com Phone: (847) 5445044

Related Public Records

Same Entity

Aesku.Diagnostics GmbH & Co. KG

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
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
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 3003825930. Last updated year: 2026. Please use registration number 3003825930 when referencing this establishment in official correspondence.