FDA.reportPublic FDA data

Parathyroid hormone (PTH) IVD, control

Definition
A material which is used to verify the performance of 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
33
Last updated
2026-10-04 01:14:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414953236IMMULITE® Systems PTH CONTROL Intact PTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103853542016-09-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)RANDOX LABORATORIES LIMITEDPTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)RANDOX LABORATORIES LIMITEDPTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)RANDOX LABORATORIES LIMITEDPTH106102025-03-24
B502BSB9330CS0Parathyroid Hormone/PTH Control SlidesBIO SB, INC.BSB-9330-CS2025-03-18
B502BSB20900Parathyroid Hormone/ PTH control slidesBIO SB, INC.Control Slides, 5 2020-06-01
B085K957M50Audit MicroControls Linearity FD iPTH for Abbott SystemsAALTO SCIENTIFICK957M-52022-01-11
B085K813M50Audit MicroControls Linearity FD iPTH Siemens AtellicaAALTO SCIENTIFICK813M-52021-03-09
B085K904M50Audit MicroControls Linearity FD iPTH for Ortho VitrosAALTO SCIENTIFICK904M-52021-03-09
B085K934M50Audit MicroControls Linearity FD iPTH for Roche SystemsAALTO SCIENTIFICK934M-52021-03-09
00850011135259ValidateLgc Clinical Diagnostics, Inc.303ro2020-12-07
00630414579177ADVIA Centaur® iPTH MCMSiemens Healthcare Diagnostics Inc.104923732020-09-24
00630414579184ADVIA Centaur® Systems QC iPTHSiemens Healthcare Diagnostics Inc.104923782020-09-24
00630414587479ADVIA Centaur® iPTH QC RefSiemens Healthcare Diagnostics Inc.106306272020-09-24
00630414599489Atellica IM PTH MCMSiemens Healthcare Diagnostics Inc.109956252020-09-24
00630414599496Atellica IM PTH QCSiemens Healthcare Diagnostics Inc.109956262020-09-24
00380740155377AlinityAbbott GmbH08P31112020-03-03
00380740156022ARCHITECTAbbott GmbH08K25132020-03-03
04987270230213Lumipulse PTH ControlsFUJIREBIO INC.2302132019-12-18
00380740017354ARCHITECTAbbott GmbH8K25-102016-06-06
00380740112776ARCHITECTAbbott GmbH8K25-122016-09-09
00380740136208AlinityAbbott GmbH08P31102018-10-24
00630414591278ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.106985972018-11-12
00630414592350ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.106991562018-11-12
00630414592404ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.106991612018-11-09
00630414979410IMMULITE® Systems PTH Calibration Verification Material Intact PTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103881052016-09-24
00884883004078MAS PTH Control Liquid Assayed PTH ControlMicrogenics CorporationPTH-MP2017-04-26
04560189210875AIA-PACK Intact PTH CONTROL SETTOSOH CORPORATIONN/A2016-09-24
05055273215328PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)RANDOX LABORATORIES LIMITEDPTH101102019-06-03
05055273215335PARATHYROID HORMONE CONTROL - LEVEL 2 (PTH CONTROL 2)RANDOX LABORATORIES LIMITEDPTH101112019-06-03
05055273215342PARATHYROID HORMONE CONTROL - LEVEL 3 (PTH CONTROL 3)RANDOX LABORATORIES LIMITEDPTH101122019-06-03
05060169690271IDS-iSYS Intact PTH Control Set IMMUNODIAGNOSTIC SYSTEMS LIMITEDIS-32302016-04-01
08056771600446LIAISON® N-TACT® PTH Gen II Control SetDiasorin Inc.3179112016-09-24