Panels › Clinical Chemistry › Product code CEW · Class 2

Radioimmunoassay, Parathyroid Hormone

Regulation 862.1545

0510(k)s in 12 months (86 all time)

0recalls in 12 months (21 all time)

20recalls that name a 510(k)

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Top companies in CEW

Company	510(k)s	Recalls
Nichols Institute Diagnostics	13	3
Diagnostic Products Corp.	10	1
Scantibodies Laboratory, Inc.	10	0
Siemens Healthcare Diagnostics	3	6
Beckman Coulter, Inc.	2	5
Diagnostic Systems Laboratories, Inc.	6	0
Roche Diagnostics	4	1
DiaSorin, Inc.	3	1
Immuno Nuclear Corp.	4	0
Ortho Clinical Diagnostics	2	2

Date	Firm and product	Code	Linked 510(k)
Oct 27, 2025	Siemens Healthcare Diagnostics, Inc. Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6; Open, Classified	CEW	K013566
Jan 3, 2025	Beckman Coulter, Inc. Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using Open, Classified	CEW	K061190
Dec 11, 2024	Beckman Coulter Inc. Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and Open, Classified	CEW	K232791
Jan 25, 2023	Future Diagnostics Solutions B.V. Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic. Open, Classified	CEW	K000471
Jan 4, 2023	Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892 Open, Classified	CEW	K101921
Nov 23, 2020	Diasorin Inc. LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Mea Terminated	CEW	K150879
Nov 22, 2016	Siemens Healthcare Diagnostics, Inc. SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; Terminated	CEW	K013566
Oct 26, 2016	Diagnostic Hybrids, Inc. Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. Terminated	CEW	K974306
Oct 5, 2016	ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative Terminated	CEW	K101921
Nov 6, 2013	Siemens Healthcare Diagnostics, Inc ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. Terminated	CEW	K020217
Jun 6, 2013	Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). Terminated	CEW	K121981
Jun 6, 2013	Siemens Healthcare Diagnostics, Inc ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). Terminated	CEW	K121981
Mar 7, 2012	Siemens Healthcare Diagnostics, Inc ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact Terminated	CEW	K020217
Dec 9, 2010	Beckman Coulter Inc. Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended fo Terminated	CEW	K896294
Dec 9, 2010	Beckman Coulter Inc. Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma Terminated	CEW	K952199
Oct 20, 2010	Beckman Coulter Inc. Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measu Terminated	CEW	K952199
May 16, 2007	Roche Diagnostics Corp. Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122. Terminated	CEW	K992680
Oct 15, 2005	Nichols Institute Diagnostics Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045. Terminated	CEW	None listed
May 10, 2005	Nichols Institute Diagnostics Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 Terminated	CEW	K033727
May 10, 2005	Nichols Institute Diagnostics Nichols IRMA Intact PTH Assay, catalog No. 40-2171 Terminated	CEW	K861797
Jul 20, 2004	Diagnostic Products Corp IMMULITE 2000 Intact PTH kit Terminated	CEW	K013566

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