Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006946274

FEI Number

3006946274

Entity Name

BIT Group France

City/State/Country

Montpellier Herault, FR

Establishment Address

Parc Euromedecine II Rue de la Valsiere, Cedex 5, Montpellier Herault 34099, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIT Group France (Owner Number: 10024699)

Owner / Operator Contact Address

Parc Euromedecine II, Montpellier Cedex 5, FR-OCC FR-34099, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CELL DYN EMERALD 22AL SYSTEM CELL DYN EMERALD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-03-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-04-22

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

BIT Group France

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012319642	BIT Group France	Mauguio Herault, FR

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

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9613959	SYSMEX CORPORATION TECHNO PARK	KOBE Hyogo, JP
3002759288	SYSMEX CORPORATION KAKOGAWA FACTORY	Kakogawa Hyogo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006946274. Last updated year: 2026. Please use registration number 3006946274 when referencing this establishment in official correspondence.