Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003601075

FEI Number

3003601075

Entity Name

BIT Analytical Solutions GmbH

City/State/Country

SCHWALBACH/TAUNUS Hesse, DE

Establishment Address

AM KRONBERGER HANG 3, SCHWALBACH/TAUNUS Hesse DE-65824, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIT Analytical Solutions GmbH (Owner Number: 9072503)

Owner / Operator Contact Address

Am Kronberger Hang 3, --, Schwalbach/Taunus, DE-NOTA DE-65824, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Siemens Healthcare Diagnostics Inc. Agilent Technologies Memphis Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Abbott Laboratories Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Abbott Laboratories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2016-03-31
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2019-04-01
JZW	Nephelometer	Immunology	Class 1	866.4540	2010-06-23
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2014-11-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2021-02-24
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2007-06-25
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-06-25
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2007-06-25
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-08-30
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2007-08-30
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-08-30
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-08-30
DCH	System, Test, C-Reactive Protein, Rhodamine	Immunology	Class 2	866.5270	2007-08-30
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2016-02-08

Official Correspondent

Valentina Peleh

US Agent Details

Bill McLain Business: Keystone Regulatory Services, LLC Email: bill.mclain@keystoneregulatory.com Phone: (717) 6569656

Related Public Records

Same Entity

BIT Analytical Solutions GmbH

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
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
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

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003601075. Last updated year: 2026. Please use registration number 3003601075 when referencing this establishment in official correspondence.