FDA.reportPublic FDA data

Total human chorionic gonadotropin (HCG) 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 total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen.
GUDID devices
15
Last updated
2023-02-22 07:22:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858022006230AdexusDx hCG Control Set (unassayed)NOWDIAGNOSTICS, INC.401.0092023-02-14
00630414973562IMMULITE® Systems HCG Calibration Verification Material HCGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103879002020-09-24
00612479202788McKessonMCKESSON MEDICAL-SURGICAL INC.50112020-03-13
20885380020275CARDINAL HEALTHCardinal Health 200, LLCB1077-242018-12-27
00780311000103SAS hCG Serum Control SetSA SCIENTIFIC, LTD.0877122018-11-01
00780311000455SAS Ultimate hCG Serum Contol SetSA SCIENTIFIC, LTD.0877152018-11-01
00780311000486SAS hCG Urine Control SetSA SCIENTIFIC, LTD.0874132018-11-01
00780311000592Sure-Vue hCG Serum Control SetSA SCIENTIFIC, LTD.0877122018-11-02
00780311000608Sure-Vue hCG-STAT Serum Control SetSA SCIENTIFIC, LTD.0877152018-11-02
00780311000615Sure-Vue hCG Urine Control setSA SCIENTIFIC, LTD.0874132018-11-02
00657498001172hCG Bi-Level Urine ControlsSTANBIO LABORATORY, L.P.1225-2052016-09-23
00657498001189hCG Tri-Level Serum ControlsSTANBIO LABORATORY, L.P.1235-3052016-09-23
00630414504742ADVIA Centaur® ThCG MCMSiemens Healthcare Diagnostics Inc.103089872016-09-24
00630414600079Atellica™ IM ThCG MCMSiemens Healthcare Diagnostics Inc.109956942018-06-05
00630414953205IMMULITE® Systems HCG CONTROL HCGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103853582016-09-24