Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8023018

FEI Number

3002807272

Entity Name

Immunotech SAS, a Beckman Coulter company

City/State/Country

MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR

Establishment Address

130 AVENUE DE LATTRE DE TASSIGNY, BP 177, MARSEILLE, CEDEX 9 Bouches-du-Rhone 13276, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BECKMAN COULTER, INC. (Owner Number: 2050012)

Owner / Operator Contact Address

250 S. Kraemer Blvd, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251995

PMA Number

N/A

All Registered Proprietary Names

ACCESS anti-HBc IgM, Access anti-HBc IgM Calibrator, Access anti-HBc IgM QC Access AMH (P/N: B13127 IE MFG) Access AMH QC (P/N: B13129) Access AMH Calibrators (P/N: B13128) Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel DxI Immunoassay System (P/N: A98857 MN MFG) Access 25(OH) Vitamin D Total for Use on the UniCel DxI Immunoassay System (P/N: A98856 MN and IE MFG) Access TPO Antibody (P/N: A12985 MN and IE MFG) Access anti-HAV Calibrator Access anti-HAV Access anti-HAV QC 7-AAD Viability Dye 150t Access Sensitive Estradiol (P/N: B84493 IE MFG) Access Estradiol (33540 MN ans IE MFG) Access Intact PTH (P/N: A16972 MN and IE MFG) Access Intact PTH Calibrators (P/N: A16953 FR MFG) Access SHBG (P/N: A48617 MN MFG) Access SHBG Calibrators Access SHBG Calibrators (P/N: A48618 FR MFG) Access SHBG QC (P/N: A48619 FR MFG) Access SHBG QC Access AMH (P/N: B13127 IE MFG) StemTrol Control Cells Stem-Kit Reagents Access HBsAg Calibrator Access HBsAg Confirmatory Access HBsAg QC Access HBsAg Access TPO Antibody Calibrators (P/N: A18227 FR MFG) Access TPO Antibody (P/N: A12985 MN and IE MFG) PerFix NC Kit (Lysing Reagent) IRIS BODY FLUIDS LYSING REAGENT AQUIOS Lysing Reagent Kit Fixative Solution (10X) OptiLyse C : Lysing Solution Lysing Solution (10X) IntraPrep Reagent 2: Permeabilization IOTest 3 Fixative VersaLyse : Lysing Solution IOTest 3 Lyse DxH 500 Series Lyse (PN B36846) Whole Blood Lysing Reagent COULTER Rinsol Cleaning Agent DxH Cell Lyse 1L & 5L AcT 5diff Fix DxH Retic Pack IMMUNOPREP REAGENT DxH diff Pack AcT 5diff Hgb Lyse COULTER DxH Cell Lyse DxH ECO Cell Lyse (5L) AcT 5diff WBC Lyse Access Red Blood Cell Folate Lysing Agent DxH ECO Cell Lyse (1L) Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG) Access Sensitive Estradiol Calibrator S0 (P/N: B97145) Access Sensitive Estradiol Calibrators (P/N: B84494) Access C-Peptide Calibrators (P/N: C31860) Access Syphilis Calibrators (P/N: C80412 MFG-BioRad) Access HIV Ag/Ab combo QC (P/N: C39452) Access HIV Ag/Ab combo Calibrators (P/N: C39451) Access HIV Ag/Ab combo (P/N: C39450) Access Free T3 Calibrator (P/N: A13430) Access Intact PTH (P/N: A16972 MN and IE MFG) Access anti-HBc Total Access anti-HBc Total Calibrator Access anti-HBc Total QC ACCESS anti-HAV IgM QC 2x4 mL (3 ea) US (D25836) ACCESS anti-HAV IgM 2x100 DET US (D25834) ACCESS anti-HAV IgM Calibrator 1x2 mL US (D25835)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2026-03-27
PQO	Anti-Müllerian Hormone Test System	Clinical Chemistry	Class 2	862.1092	2017-12-12
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-01-22
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2015-01-22
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2024-08-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-12-15
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2025-12-15
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2025-12-15
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2010-11-15
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1992-07-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-08-14
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2008-08-14
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-10-28
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2009-10-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-10-28
PQO	Anti-Müllerian Hormone Test System	Clinical Chemistry	Class 2	862.1092	2023-02-08
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-11
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2025-12-15
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	1988-06-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	1988-06-17
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1977-12-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-02-02
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2024-02-29
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-09-10
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2024-03-07
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2026-03-05
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2026-02-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-02-11
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2026-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

Ian Pilcher Business: Beckman Coulter, Inc. Email: ipilcher@beckman.com Phone: (443) 3506459

Related Public Records

Same Entity

BECKMAN COULTER, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3021394862	Beckman Coulter Biomedical GmbH	Baierbrunn Bavaria, DE
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
DEN150057	Roche Diagnostics	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	2016-12-19
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8023018. Last updated year: 2026. Please use registration number 8023018 when referencing this establishment in official correspondence.