FDA.reportPublic FDA data

Carcinoembryonic antigen (CEA) 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 carcinoembryonic antigen (CEA) in a clinical specimen.
GUDID devices
13
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04560189212244AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONN/A2019-07-25
B502BSB9117CS0CEA Control SlidesBIO SB, INC.BSB-9117-CS2025-03-18
B502BSB9249CS0CEACAM7 Control SlidesBIO SB, INC.BSB-9249-CS2025-03-18
B502BSB53430CEA control slidesBIO SB, INC.Control Slides, 52020-06-01
14560189212241AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONN/A2019-07-25
00630414971179IMMULITE® Systems CEA Calibration Verification MaterialSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103736842020-09-24
B502BSB65400CEA Control SlidesBIO SB, INC.Control Slides, 52020-08-31
00859110005722ValidateLgc Clinical Diagnostics, Inc.407re2020-03-02
00859110005739ValidateLgc Clinical Diagnostics, Inc.407sa2020-03-02
00630414126302ADVIA Centaur® CEA MCMSiemens Healthcare Diagnostics Inc.103116242016-09-24
00630414598536Atellica IM CEA MCMSiemens Healthcare Diagnostics Inc.109955262018-02-06
00380740014551ARCHITECTAbbott Ireland Diagnostics07K68-122016-09-09
00380740130848AlinityAbbott Ireland Diagnostics07P62102018-12-31