ADVIA Centaur Intact Parathyroid Hormone (iPTH)

Registration Details

Registration Name: Siemens Healthcare Diagnostics Inc.
Registration Number: 1219913
FEI Number: 1219913
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 333 Coney Street
City: E Walpole
State: MA
ZIP: 02032
Country: US

Regulatory Submissions

510(k) Number: K041133

Owner / Operator

Firm Name: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Operator Number: 9096044
Address: Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
City: Tarrytown
State: NY
Postal Code: 10591
Country: US
Correspondent: Mary Seeger

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Ige, Antigen, Antiserum, Control	DGC	Class 2	Immunology	No	2008-01-02
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2008-01-02
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	Class 2	Clinical Chemistry	No	2008-01-02
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2008-01-02
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2008-01-02
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2008-01-02
Acid, Folic, Radioimmunoassay	CGN	Class 2	Clinical Chemistry	No	2008-01-02
Radioimmunoassay, Total Triiodothyronine	CDP	Class 2	Clinical Chemistry	No	2008-01-02
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	Class 1	Clinical Chemistry	No	2008-01-02
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2008-01-02
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	Class 2	Clinical Toxicology	No	2008-01-02
Fluorescence Polarization Immunoassay, Theophylline	LGS	Class 2	Clinical Toxicology	No	2008-01-02
Radioimmunoassay, Progesterone	JLS	Class 1	Clinical Chemistry	No	2008-01-02
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	Class 1	Clinical Chemistry	No	2008-01-02
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2008-01-02
Radioimmunoassay, Parathyroid Hormone	CEW	Class 2	Clinical Chemistry	No	2008-01-02
Radioimmunoassay, Luteinizing Hormone	CEP	Class 1	Clinical Chemistry	No	2008-01-02
Radioimmunoassay, Vancomycin	LEH	Class 2	Clinical Toxicology	No	2008-01-02
Calibrators, Drug Mixture	DKB	Class 2	Clinical Toxicology	No	2008-01-02
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2008-01-02
Visual, Pregnancy Hcg, Prescription Use	JHI	Class 2	Clinical Chemistry	No	2008-01-02
Urinary Homocystine (Nonquantitative) Test System	LPS	Class 2	Clinical Chemistry	No	2008-01-02
Fluorescent Immunoassay, Tobramycin	LCR	Class 2	Clinical Toxicology	No	2008-01-02
Radioimmunoassay, Prolactin (Lactogen)	CFT	Class 1	Clinical Chemistry	No	2008-01-02
Radioassay, Vitamin B12	CDD	Class 2	Clinical Chemistry	No	2008-01-02
Enzyme Immunoassay, Gentamicin	LCD	Class 2	Clinical Toxicology	No	2008-01-02
System, Test, Thyroid Autoantibody	JZO	Class 2	Immunology	No	2008-01-02
Radioimmunoassay, Free Thyroxine	CEC	Class 2	Clinical Chemistry	No	2008-01-02
Radioassay, Triiodothyronine Uptake	KHQ	Class 2	Clinical Chemistry	No	2008-01-02

Proprietary Names

ADVIA Centaur Intact Parathyroid Hormone (iPTH) ADVIA Centaur CP ADVIA Centaur XP ADVIA Centaur ADVIA Centaur XPT Atellica IM Ancillary Probe Wash 3 (APW3) Atellica IM Total Triiodothyronine Diluent (T3 DIL) Atellica IM Total Triiodothyronine Master Curve Material (T3 MCM) Atellica IM Total Triiodothyronine (T3) Analyser, ADVIA Centaur XP Atellica IM Ancillary Probe Wash 1 (APW1) ADVIA Centaur T3 ADVIA Centaur Acid and Base Reagent Kit CP ADVIA Centaur Acid and Base Reagents

Establishment Types

Manufacture Medical Device