FDA.reportPublic FDA data

Lipoprotein A IVD, calibrator

Definition
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.
GUDID devices
18
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414285009N LP(a) Standard SYSiemens Healthcare Diagnostics Products GmbH108736862020-10-12
04015630930609Preciset Lp(a) Gen.2Roche Diagnostics GmbH058526411902025-05-27
08058056680228Lp(a) Cal SetSENTINEL CH. SPA11522D2024-03-15
04015630933914Preciset Lp(a) Gen.2Roche Diagnostics GmbH58526411602021-01-18
00630414287430N LP(a) Standard SYSiemens Healthcare Diagnostics Products GmbH108736862020-10-12
00380740157432ARCHITECTABBOTT LABORATORIES05P83022020-03-03
00380740153816AlinityABBOTT LABORATORIES01R14012019-05-10
15099590575137IMMAGEBeckman Coulter, Inc.4653652016-08-24
05055273204438Lp(a) CAL SETRANDOX LABORATORIES LIMITEDLP34042016-09-16
00842768007224N Lp(a) Standard SYSiemens Healthcare Diagnostics Products GmbH104460382016-09-24
00816426020573K-ASSAY® Lp(a) CalibratorKAMIYA BIOMEDICAL COMPANY, LLCKAI-018C2016-09-16
00817089020368DiazymeDIAZYME LABORATORIES, INC.DZ131A-CAL2016-11-03
00817089020382DiazymeDIAZYME LABORATORIES, INC.DZ131B-CAL2016-11-03
00817439021076MedTest DX Lipoprotein (a) CalibratorMedtest Dx, Inc.LPAC4002016-09-30
00811727011831Pointe Scientific, Inc. Lipoprotein (a)HORIBA INSTRUMENTS INCORPORATEDL7597-CAL2016-08-31
00630414558257ADVIA® Chemistry LP(A) CALIBRATORSiemens Healthcare Diagnostics Inc.102850172016-09-24
00630414597546Atellica CH Lp(a) CalibratorSiemens Healthcare Diagnostics Inc.110994332018-02-06
00380740100926ARCHITECTABBOTT LABORATORIES5P83-012016-09-09