Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610746

FEI Number

3002806557

Entity Name

BIOKIT S.A.

City/State/Country

LLISSA D AMUNT Barcelona, ES

Establishment Address

AV. CAN MONTCAU 7, LLISSA D AMUNT Barcelona 08186, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOKIT S.A. (Owner Number: 8030752)

Owner / Operator Contact Address

AV CAN MONTCAU, 7, --, LLISSA D'AMUNT, BARCELONA, ES-B 08186, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rheumajet RF HemosIL Homocysteine Controls HemosIL Homocysteine Alinity c Ferritin/IgE/Myoglobin Control Kit Alinity c IgE Calibrators QUANTIA IgE / Ferritin / Myoglobin Control QUANTIA IgE Calibrator QUANTIA IgE Alinity c IgE Reagent Kit Alinity c A1-Antitrypsin Reagent Kit QUANTIA Proteins Control QUANTIA A1-AT QUANTIA Proteins Calibrator HemosIL D-Dimer HS ARCHITECT iDigoxin Calibrators ARCHITECT iDigoxin BIO-FLASH ARCHITECT C-Peptide Alinity i C-Peptide Reagent Kit HemosIL D-Dimer HS 500 Controls QUANTA Flash aCL IgM Controls HemosIL AcuStar Anti-Cardiolipin IgM Controls QUANTA Flash aCL IgG Controls QUANTA Flash aCL IgM HemosIL AcuStar Anti-Cardiolipin IgM HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgG QUANTA Flash aCL IgG Alinity c B2-Microglobulin Reagent Kit ARCHITECT iVancomycin Quantia ASO Control I Alinity i Intact PTH Reagent Kit ARCHITECT iPTH Calibrators ARCHITECT iPTH ARCHITECT iPTH Controls HemosIL Von Willebrand Factor Activity ARCHITECT C-Peptide Controls ARCHITECT C-Peptide Calibrators HemosIL AcuStar Anti-B2 Glycoprotein-I IgG QUANTA Flash B2 GP1 IgM Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgM QUANTA Flash B2 GP1 IgG QUANTA Flash B2 GP1 IgM QUANTA Flash B2 GP1 IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls AcuStar BIO-FLASH HemosIL AcuStar D-Dimer HemosIL AcuStar D-Dimer Controls QUANTIA B2-Microglobulin QUANTIA Proteins Control QUANTIA B2-Microglobulin Calibrator ADVIA Centaur Herpes-1 IgG (HSV1) Atellica IM Herpes-1 IgG (HSV1) HemosIL Factor XIII HemosIL D-Dimer HS 500 Controls Lp(a) control Lp(a) calibrators QUANTIA Ferritin QUANTIA Ferritin Calibrator ADVIA Centaur® Anti-HBe2 (aHBe2) assay ADVIA Centaur® Anti-HBe2 Quality Control (aHBe2 QC) Atellica® IM Anti-HBe2 (aHBe2) Atellica® IM Anti-HBe2 Quality Control (aHBe2 QC) Alinity i DHEA-S Calibrators Alinity i Intact PTH Calibrators Alinity i C-Peptide Calibrators Alinity c Lp(a) Calibrators Alinity c B2-Microglobulin Calibrator Alinity c ASO Calibrator ARCHITECT DHEA-S Controls ARCHITECT DHEA-S Calibrators Alinity i HSV-2 IgG Calibrator Alinity i HSV-2 IgG Alinity i HSV-2 IgG Controls HemosIL D-Dimer controls HemosIL Free Protein S HemosIL D-Dimer ADVIA Centaur EBV-EBNA IgG Quality Control ADVIA Centaur EBV-EBNA IgG ADVIA Centaur EBV-VCA IgM Quality Control ADVIA Centaur EBV-VCA IgM HemosIL von Willebrand Factor Antigen Alinity c Proteins Control Kit QUANTA Flash aPL Multi Controls HemosIL CL Multi-Ab Controls Alinity c A-1-AGP Reagent Kit QUANTIA A-1-AGP ADVIA Centaur Herpes-2 IgG (HSV2) Atellica IM Herpes-2 IgG (HSV2) Monogen Alinity i DHEA-S Controls Alinity c Lp(a) Control Kit Alinity i C-Peptide Controls Alinity c ASO Control II Alinity i Intact PTH Controls Alinity c ASO Control I Atellica IM Herpes-2 IgG Quality Control (HSV2 QC) Atellica IM Herpes-1 IgG Quality Control (HSV1 QC) ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2008-01-17
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2007-02-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-02-15
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-10-17
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2005-10-17
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-10-17
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2023-07-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-10-17
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2005-10-17
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-10-17
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2018-11-19
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2009-01-21
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2009-01-21
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2023-10-23
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2008-09-25
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2012-12-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-12-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-12-01
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2011-12-01
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2018-12-05
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2013-12-13
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-01-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-08-13
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2007-08-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-08-13
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2015-12-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-12-01
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2011-12-01
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2011-12-01
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2011-12-01
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2011-12-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	1996-03-20
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	1996-03-20
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	1996-03-20
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2018-10-15
DBT	Factor Xiii A, S, Antigen, Antiserum, Control	Immunology	Class 1	866.5330	2005-10-17
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2017-03-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-12-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-03
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2005-10-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-10-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2005-10-17
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2021-08-03
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2021-08-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-07-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-10-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2005-10-17
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2025-08-25
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2025-08-25
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2008-01-17
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2008-01-17
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2023-10-23
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2025-12-02
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2025-12-02
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2025-12-02
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2023-10-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-12-05
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2005-10-17
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2018-10-15
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2018-10-15
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2008-01-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-07-13

Official Correspondent

ANGELS ROMA

US Agent Details

Carol Marble Email: cmarble@werfen.com Phone: (800) 9559525

Related Public Records

Same Entity

BIOKIT S.A.

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
K061598	Instrumentation Laboratory CO	HEMOSIL HOMOCYSTEINE AND CONTROLS	2006-09-22
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0002-2018	The Binding Site Group, Ltd.	2	Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610746. Last updated year: 2026. Please use registration number 9610746 when referencing this establishment in official correspondence.