Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002637618

FEI Number

3002637618

Entity Name

Siemens Healthcare Diagnostics Inc

City/State/Country

East Walpole, MA, US

Establishment Address

Point Of Care Headquarters, 333 Coney St, East Walpole, MA 02032, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K113216

PMA Number

N/A

All Registered Proprietary Names

RapidQC Plus Blood Gas Systems Controls Hema-Chek CLINITEK Family (500, 200, 100) CLINITEK Advantus Hemastix Stratus CS CTNI CalPak Rapidpoint 400/405/500 systems Pleural Fluid Stratus CS Acute Care MYO TestPak Stratus CS Acute Care CKMB TestPak Stratus CS Acute Care CTNI CalPak Stratus CS Acute Care CKMB CalPak Stratus CS Acute Care CTNI TestPak Stratus CS Acute Care MYO CalPak SCS CKMB CalPak SCS Rotors SCS Cannula (BD) SCS Cannula (Sarstedt) SCS Printer Paper SCS Sample Cup SCS Pipette Tips SCS Cannula (Terumo) Stratus CS Analyzer SCS Waste Bin Liner Clinitek Atlas Pro 12 Reagent Pak CLINITEK Microalbumin Reagent Strip CLINITEK Microalbumin 2 Reagent ADVIA Centaur Vitamin D Total (VitD) Atellica IM Vitamin D Total (VitD) CLINITEK Novus 10 Urinalysis Cassette CLINITEK Novus Calibration Kit CLINITEK Novus Automated Urine Chemistry Analyzer Clinitest hCG SCS CKMB DilPak ADVIA Centaur BR Assay (BR) Atellica IM BR 27.29 (BR) SCS CTNI DilPak Stratus CS Acute Care PBNP TestPak RAPIDPoint® 500e Blood Gas System iCa++ Quick Sampler Atellica IM Total IgE Diluent (tIgE DIL) Atellica IM Total IgE (tIgE) Stratus CS BHCG TestPak Stratus CS BHCG CalPak Stratus CS Acute Care DDMR CalPak Stratus CS Acute Care DDMR TestPak SCS MYO CalPak SCS MYO TestPak Clinistix Kidney Health Test Kit RapidQC CVM ADVIA Centaur NT-proBNP Master Curve Material (PBNP MCM) Atellica IM VitDII Quality Control (VitDII QC) ADVIA Centaur Lipopolysaccharide Binding Protein Quality Control (LBP QC) Regulator Cal Gas Gas Cartridge Pak Slope Gas 10%CO2 Bal N2 Cal Gas 5% 12% O2 ADVIA Centaur TSH3-Ultra (TSH3ULII) Atellica IM TSH3-Ultra (TSH3ULII) POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite RAPIDPOINT 405 Rapidpoint 400 Series Blood Gas Systems Family Atellica IM Vitamin D Total II (VitDII) Atellica IM VitDII Diluent (VitDII DIL) Stratus CS DDMR TestPak DCA Systems DCA 2000+ DCA Systems HbA1c Reagent Kit DCA Systems HbA1c Controls DCA 2000 DCA HbA1c Normal and Abnormal Controls Ictotest Stratus CS D-Dimer TestPak DDMRE Clinitek Status+ Clinitek Status CT Status CT Status+ Urin-Tek, Urine Collection System RapidQC Hct 800 SERIES M860 Clinitek Novus Positive Control Strips Atlas Negative Control Clinitek Atlas 12 Atlas Cal Kit Atlas Clarity Calibrator Atlas Positive Control Clinitek Atlas CLINITEK Atlas Carosel Clinitek Family CLINITEK Atlas Rack Clinitek Atlas 10 Clinitek Novus Negative Control Strips Clinistix UTI Test Strips REGULATOR. PRESSURE GAS CYLINDER DCA Systems HbA1c Reagent Kit DCA 2000 DCA 2000+ RapidLab 1200 nBili Activation Key Stratus CS Acute Care CCRP TestPak SCS MYO CalPak Rapidpoint 400 Rapidpoint Blood Gas Blood Gas Systems Family Stratus CS Acute Care PBNPM CalPak Stratus CS Acute Care PBNP TestPak Stratus CS Acute Care BHCG CalPak Stratus CS Acute Care BHCG TestPak Stratus CS Acute Care PBNP CalPak Microalbustix reagent strips AZO Test Strips Multistix GP reagent strips Multistix Reagent Strip Family N-Multistix SG reagent strips Multistix 5 Acetest Reagent Tablets N-Labstix reagent strips Multistix SG Family Hemacombistix Uristix Multistix 7 Hemastix Uristix 4 Labstix Albustix Combistix SG reagent strips Combistix Multistix 9 Multistix 10 SG Reagent Strips Multistix 8 SG Multistix Pro 10LS 100 Multistix Labstix SG reagent strips Multistix Pro 10LS 25 Multistix Reagent Strips Multistix 9 SG Multistix 10 Azostix Multistix Pro Reagent Strip Family Q-ity UA 10 Visual Urine Strips GAS, CALIBRATION (SPECIFIED CONCENTRATION (Cal Gas) DCA Systems DCA Systems M/C Controls DCA Systems Microalbumin/Creatinine DCA Systems M/C Reagent Kit Stratus CS Acute Care CCRP CalPak Chek-Stix Chek-Stix Combo Pak Chek-Stix Control Strips CLINITEK family ADVIA Centaur B-type Natriuretic Peptide (BNP) Atellica IM B-type Natriuretic Peptide (BNP) Atellica IM Cortisol (Cor) ADVIA Centaur Cortisol (Cor) Atellica IM Digoxin (DIG) ADVIA Centaur Digoxin (DIG) CLINITEK family Chek-Stix Negative Control Strips Rapidpoint 500 MCart with calibrator RP500 MCart calibrator DCA Systems DCA Vantage Rapidpoint 500 System Lactate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	1998-06-16
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2009-01-05
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-01-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-01-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-01-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-01-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-01-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-01-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-01-18
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-01-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-01-18
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-01-18
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-01-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2013-05-29
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-11-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-27
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-03-31
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-03-31
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-03-31
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-03-31
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-03-31
JIP	Blood, Occult, Enzymatic Method, In Urine	Hematology	Class 2	864.6550	2008-03-31
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-03-31
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-03-31
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-03-31
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-03-31
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-03-31
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-03-31
CJG	Tetrabromo-M-Cresolsulfonphthalein, Albumin	Clinical Chemistry	Class 2	862.1035	2008-01-18
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-18
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2025-12-15
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2014-11-24
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2014-11-24
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2014-11-24
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2014-11-24
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2014-11-24
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2014-11-24
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-11-24
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2014-11-24
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2014-11-24
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2014-11-24
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2014-11-24
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2014-11-24
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2008-01-18
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-27
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2007-11-27
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2025-12-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-11-27
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2007-11-15
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2020-03-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2020-03-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2020-03-30
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2020-03-30
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2020-03-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2020-03-30
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2020-03-30
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2020-03-30
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2020-03-30
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2025-12-15
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-11-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-14
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-11-15
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-11-27
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2023-01-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2023-01-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-01-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-03-18
BXX	Calibrator, Pressure, Gas	Anesthesiology	Class 1	868.2620	2013-01-04
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2026-02-17
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2000-02-07
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2006-08-01
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2026-03-18
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-11-15
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-01-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-07-26
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2011-05-20
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2010-01-26
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2010-01-26
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2010-01-26
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2010-01-26
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2010-01-26
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2010-01-26
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2010-01-26
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2010-01-26
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2010-01-26
JIP	Blood, Occult, Enzymatic Method, In Urine	Hematology	Class 2	864.6550	2010-01-26
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2010-01-26
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2010-01-26
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2010-01-26
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-01-22
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2010-02-05
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2010-01-27
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-03-13
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2023-01-13
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2023-01-13
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2020-07-02
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-09-18
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2010-02-05
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	1998-06-16
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	1998-06-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	1998-06-16
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	1998-06-16
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	1998-06-16
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	1998-06-16
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	1998-06-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-11-15
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2007-11-15
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-01-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-01-18
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-18
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-01-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-01-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-01-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-01-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-01-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-01-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-01-18
BXK	Gas, Calibration (Specified Concentration)	Anesthesiology	Class 1	868.6400	2020-07-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-15
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-25
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2025-12-15
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2025-12-15
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2025-12-15
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-25
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-13
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-18
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-01-18
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-05-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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

Registration Number	Establishment Name	Location
3012817228	Epocal Inc	Ottawa Ontario, CA
3011194542	Siemens Healthcare GmbH	Berlin, DE
3009448641	Siemens Healthcare Diagnostics, Inc.	Mishawaka, IN, US
3004959793	EPOCAL, INC.	Ottawa Ontario, CA
9610633	SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD	SUDBURY Suffolk, GB

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K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0102-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Z-0103-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Z-0104-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Z-0105-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Z-0106-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Z-0107-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Z-0108-2014	Siemens Healthcare Diagnostics Inc	2	Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

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2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
2016706	Bio-Rad Laboratories Inc.	IRVINE, CA, US
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL
9610746	BIOKIT S.A.	LLISSA D AMUNT Barcelona, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002637618. Last updated year: 2026. Please use registration number 3002637618 when referencing this establishment in official correspondence.