FDA.reportPublic FDA data

Parathyroid hormone (PTH) IVD, calibrator

Definition
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen.
GUDID devices
21
Last updated
2024-08-08 18:46:09

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613336170311CalSet PTHRoche Diagnostics GmbH089284521902024-07-30
07613336170328CalSet II PTHRoche Diagnostics GmbH089284871902024-07-30
07613336173497CalSet PTH STATRoche Diagnostics GmbH089285091902024-07-30
00630414472553ADVIA Centaur® Systems iPTH CalibratorSiemens Healthcare Diagnostics Inc.103090422020-09-24
00380740155360AlinityAbbott GmbH08P31022020-03-03
00380740156039ARCHITECTAbbott GmbH08K25042020-03-03
04987270230206Lumipulse G Whole PTH CalibratorsFUJIREBIO INC.2302062019-12-18
00380740017347ARCHITECTAbbott GmbH8K25-012016-06-06
00380740112769ARCHITECTAbbott GmbH8K25-032016-09-09
00380740131586AlinityAbbott GmbH08P31012018-10-24
00630414579191ADVIA Centaur® Systems iPTH CalibratorSiemens Healthcare Diagnostics Inc.104923872016-09-24
00630414579207ADVIA Centaur® Systems iPTH CalibratorSiemens Healthcare Diagnostics Inc.104923942016-09-24
00630414587486ADVIA Centaur® iPTH CalibratorSiemens Healthcare Diagnostics Inc.106306282016-09-24
04015630913121Elecsys PTH CalSetRoche Diagnostics GmbH119722191222016-09-20
04015630922895Elecsys PTH STAT CalSetRoche Diagnostics GmbH48941381902016-09-20
04015630940776CalSet PTHRoche Diagnostics GmbH073608941902017-04-17
04560189211421ST AIA-PACK Intact PTH CALIBRATOR SETTOSOH CORPORATIONN/A2016-09-24
05060169690950IDS-iSYS Intact PTH Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LIMITEDIS-32352016-04-01
07613336147672CalSet PTHRoche Diagnostics GmbH082438751902018-03-21
07613336147689CalSet II PTHRoche Diagnostics GmbH082438911902018-03-21
07613336147696CalSet PTH STATRoche Diagnostics GmbH082439301902018-03-21