Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610806

FEI Number

3001644026

Entity Name

Siemens Healthcare Diagnostics Products GmbH

City/State/Country

MARBURG Hesse, DE

Establishment Address

76 EMIL-VON-BEHRING STRASSE, MARBURG Hesse 35041, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)

Owner / Operator Contact Address

Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171072

PMA Number

N/A

All Registered Proprietary Names

Berichrom Heparin LMW Control 1 Berichrom Heparin LMW Calibrator Berichrom Heparin LMW Control 2 N Latex RF Kit N Latex IgA BN II Evaporation Stoppers N Cuvettes Segments for BN II BN II System IMMULITE Probe Wash Module IMMULITE Probe Cleaning Kit IMMULITE 2000 / XPi Probe Cleaning Kit IMMULITE 2000 / XPi Probe Wash Module TRF, PROT3 CON Dade Ci-Trol Heparin Control, Low Dade Ci-Trol Heparin Control, High N Antiserum to Human a1-Antitrypsin Dimension Vista sTFR Flex N Protein Standard PY Clotting Factor V Deficient Plasma Dimension Vista CDT Flex N Latex Cystatin C N Latex IgM Batroxobin Reagent Dimension Vista KAPPA Flex Dimension Vista PROT1 CON H Dimension Vista LAMBDA Flex Dade Hepzyme N Latex FLC kappa N Latex FLC lambda Enzygnost TAT micro N AS IgG1 N AS IgG3 N AS IgG4 N AS IgG2 N a1-Microglobulin Kit Coag Factor XI Deficient Plasma Coag Factor IX Deficient Plasma Coag Factor VIII Deficient Plasma Coag Factor XII Deficient Plasma N Latex FLC kappa N Latex FLC lambda Dimension Vista hsCRP Control L Dimension Vista hsCRP Control H Dimension Vista hsCRP Felx Dimension Vista IGG3 Flex Dimension Vista IGG4 Flex Dimension Vista IGG1 Flex Dimension Vista IGG2 Flex Vista PROT1 Cal Vista PROT1 CON M Vista PROT1 CON L Vista B2MIC Flex INNOVANCE Apixaban Controls INNOVANCE Apixaban Standards INNOVANCE Anti-Xa ProC Control Plasma Control Plasma N N Apolipoprotein Standard Serum BN II Additive N Predilution Wells N Evaporation Caps for Control Vials (2.5 mL) BN ProSpec System CLEANER SCS N Cuvettes Segments for BN ProSpec Factor VIII Chromogenic Assay Berichrom Plasminogen Dade Cluster Platelet Aggregation Reagents INNOVANCE Heparin Calibrator INNOVANCE Heparin LMW Control 2 INNOVANCE Heparin UF Control 1 INNOVANCE Heparin INNOVANCE Heparin LMW Control 1 INNOVANCE Heparin UF Control 2 Dimension Vista sALB Flex reagent cartridge (sALB) Atellica CH Urine Albumin (UAlb) INNOVANCE D-Dimer Controls INNOVANCE D-Dimer Sample Diluent N Latex Ferritin Behring Coagulation Cup vWF Ag Sickle-Sol Tests Enzygnost F1+2 monoclonal Berichrom Protein C Dimension Vista A1AT Flex Atellica CH Alpha-1-Antitrypsin 2 (AAT2) ADVIA 2120 and ADVIA 2120i Aspiration pathway Wash Kit ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash Kit Neodisher GK ADVIA 2120 and ADVIA 2120i Perox Flow cell wash kit ADVIA 2120 and ADVIA 2120i Vent Line Wash Kit BC Thrombin Reagent Factor V Leiden QuikLYTE IMT Std A QuikLyte IMT Std B Dimension Sample Cups with Lids Dimension CA Flex Dimension BUN Flex Dimension CHEM I Cal Purified Water Diluent Dimension Enzyme Verifier Dimension Cuvette Cartridge Dimension Salt Bridge Solution Apolipoprotein Control Serum CHD Dade Fibrinogen Determination Reagents Berichrom Heparin UF Calibrator Berichrom Heparin UF Control 1 Berichrom Heparin UF Control 2 Atellica CH Protein 1 Calibrator (PROT1 CAL) Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL) Atellica CH Bilirubin Calibrator (BILI CAL) N Latex FLC Lambda N Latex FLC Kappa Standard Human Plasma N Latex IgE mono N Latex CDT Kit N Antiserum to Human-Ig/L-chain, λ type N Antiserum to Human-Ig/L-chain, k type N/T Rheumatology Control SL/2 N/T Rheumatology Control SL/1 RapiTex RF INNOVANCE Free PS Ag Dade Innovin Dimension Vista PROT3 Cal Berichrom a2-Antiplasmin Dade Actin FS Activated PTT Reagent Dade PFA Trigger Solution Dade PFA Priming Cartridges PFA-100 System Dade PFA Vacuum Cups Dade PFA Collagen/ADP Test Cartridges Dade PFA Collagen/EPI Test Cartridges Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) BCS XP System BCS System Cuvette Rotors BC Vial Kit LA 2 Confirmation Reagent LA 1 Screening Reagent N Lp (a) Control SY N Antiserum to Human Transferrin N Latex B2-Microglobulin Berichrom Heparin Fibrinogen Calibrator Kit CardioPhase hsCRP N Latex ASL Dimension Vista ASL Flex Atellica CH Anti-Streptolysin-O_2 (ASO_2) Atellica CH Anti-Streptolysin-O_3 (ASO_3) ADVIA Chemistry Dade Actin Activated Cephaloplastin Reagent Multifibren U Dimension Vista IGE Flex N Antiserum to Human Hemopexin Dimension Vista HPX Flex Protein C Reagent INNOVANCE D-Dimer BC von Willebrand Reagent Dimension Vista C4 Flex Dimension Vista C3 Flex Dimension Vista A1AG Flex Atellica CH Alpha-1-acid Glycoprotein (AAG) Dimension Vista HAPT Flex Atellica CH Haptoglobin_2 (Hapt_2) ADVIA Chemistry HAPT N Lp (a) Standard SY N Rheumatology Standard SL N Antiserum to Human C1 Inhibitor INNOVANCE VWF Ac N FLC Standard SL N FLC Supplementary Reagent N FLC Control SL1 N FLC Control SL2 Hematek 3000 Hema-Tek Slide Stainer Hematek Dade Ci-Trol Coagulation Control Level 1 N Antiserum to Human-a2-Macroglobulin Dimension Vista PREALB Flex N Antiserum to Human Prealbumin Atellica CH Prealbumin (PALB) Dimension Vista APO Control Dimension Vista APO Cal Dimension Vista APOAI Flex Dimension Vista APOB Flex N Antiserum to Human C3c N Antiserum to Human C4 Dimension Vista A1MIC Flex N Protein Standard UY N Protein Standard UY N Latex Cystatin C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2009-04-02
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2009-04-02
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2009-04-02
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2007-12-05
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-04
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2007-12-05
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-05
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-12-05
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-05
DCH	System, Test, C-Reactive Protein, Rhodamine	Immunology	Class 2	866.5270	2007-12-05
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2009-05-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-10-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-10-21
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2008-10-21
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-05
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-05
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2009-03-06
NAO	Test, Carbohydrate Deficient Transferrin	Clinical Chemistry	Class 1	862.1360	2011-04-22
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2007-12-04
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-12-04
JCO	Bothrops Atrox Reagent	Hematology	Class 2	864.8100	2007-12-05
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2009-01-27
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2009-01-27
JBR	Test, Heparin Neutralization	Hematology	Class 2	864.7525	2007-12-05
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2021-11-04
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2021-11-04
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2007-12-05
DAS	Igg (Fc Fragment Specific), Antigen, Antiserum, Control	Immunology	Class 1	866.5530	2008-02-01
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2007-12-05
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-05
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2021-03-04
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2021-03-04
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-12-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-02
DFZ	Igg (Gamma Chain Specific), Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2009-12-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-04-02
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2009-04-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-04-02
QLU	Anti-Factor Xa Activity Test System, Apixaban	Hematology	Class 2	864.7295	2024-10-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-04
JZW	Nephelometer	Immunology	Class 1	866.4540	2007-11-14
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-05
DDX	Plasminogen, Antigen, Antiserum, Control	Immunology	Class 1	866.5715	2007-12-05
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2007-12-05
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2017-08-24
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2017-08-24
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2017-08-24
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2004-07-14
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2008-12-10
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2007-12-05
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2013-03-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2023-06-05
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2023-06-05
GHM	Test, Sickle Cell	Hematology	Class 2	864.7825	2007-12-12
MIF	Prothrombin Fragment 1.2	Hematology	Class 2	864.7320	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-05
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2007-12-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-04
JCB	Detergent	Pathology	Class 1	864.4010	2007-12-04
GJA	Test, Thrombin Time	Hematology	Class 2	864.7875	2007-12-05
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2011-11-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-11-15
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
GFK	Fibrinogen Determination Standards And Controls	Hematology	Class 2	864.7340	2007-12-05
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2009-04-02
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2009-04-02
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2009-04-02
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2023-04-10
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2022-03-30
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2022-03-30
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2007-12-04
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-05
NAO	Test, Carbohydrate Deficient Transferrin	Clinical Chemistry	Class 1	862.1360	2007-12-05
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2007-12-05
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2018-09-17
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-05
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-05
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2007-11-14
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2024-01-25
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-01-25
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-04
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2007-12-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-12-05
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2007-12-04
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-05
GFX	Fibrinogen Standard	Hematology	Class 2	864.7340	2007-12-05
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2023-12-04
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2023-12-04
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2003-07-15
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-05
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2007-12-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-02
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-02
CZX	Hemopexin, Antigen, Antiserum, Control	Immunology	Class 2	866.5490	2007-12-04
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-04
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2011-01-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-02
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-02
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-02
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2007-12-02
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2002-07-06
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-05
DBA	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control	Immunology	Class 2	866.5250	2007-12-05
QTY	Von Willebrand Factor Assay	Hematology	Class 2	864.7293	2022-09-30
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2017-12-07
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2017-12-07
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2011-12-27
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-05
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2007-12-05
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2003-01-16
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-04
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2007-12-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-04
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-04
DCO	Alpha-Globulin, Antigen, Antiserum, Control	Immunology	Class 1	866.5400	2007-12-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-06-12
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2017-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

Mary Seeger Business: SIEMENS HEALTHCARE DIAGNOSTICS INC. Email: mary.seeger@siemens-healthineers.com Phone: (914) 3254329

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.

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

View Entity Profile →

Other Registrations for Same Entity

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610806. Last updated year: 2026. Please use registration number 9610806 when referencing this establishment in official correspondence.