ADVIA Centaur Intact Parathyroid Hormone (iPTH)

Registration Details

Registration Name: Siemens Healthcare Diagnostics Inc.
Registration Number: 2432235
FEI Number: 2432235
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 511 Benedict Ave
City: Tarrytown
State: NY
ZIP: 10591
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

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility