FDA.reportPublic FDA data

Cytokeratin 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 one or multiple cytokeratin subtype(s) in a clinical specimen.
GUDID devices
53
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414292779Siemens Healthineers CYFRA 21-1 MCMSiemens Healthcare Diagnostics Inc.115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCMSiemens Healthcare Diagnostics Inc.115361882026-04-16
B502BSB27320Cytokeratin 17 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB9134CS0Cytokeratin 14 Control SlidesBIO SB, INC.BSB-9134-CS2025-03-18
B502BSB9137CS0Cytokeratin 17 Control SlidesBIO SB, INC.BSB-9137-CS2025-03-18
B502BSB9138CS0Cytokeratin 18 Control SlidesBIO SB, INC.BSB-9138-CS2025-03-18
B502BSB9139CS0Cytokeratin 19 Control SlidesBIO SB, INC.BSB-9139-CS2025-03-18
B502BSB9140CS0Cytokeratin 20 Control SlidesBIO SB, INC.BSB-9140-CS2025-03-18
B502BSB9141CS0Cytokeratin 35BH11 Control SlidesBIO SB, INC.BSB-9141-CS2025-03-18
B502BSB9142CS0Cytokeratin 4 Control SlidesBIO SB, INC.BSB-9142-CS2025-03-18
B502BSB9145CS0Cytokeratin 5 & 6 Control SlidesBIO SB, INC.BSB-9145-CS2025-03-18
B502BSB9149CS0Cytokeratin 7 Control SlidesBIO SB, INC.BSB-9149-CS2025-03-18
B502BSB9150CS0Cytokeratin 7 & CDX2 Control SlidesBIO SB, INC.BSB-9150-CS2025-03-18
B502BSB9151CS0Cytokeratin 8 Control SlidesBIO SB, INC.BSB-9151-CS2025-03-18
B502BSB9152CS0Cytokeratin 8 & 18 Control SlidesBIO SB, INC.BSB-9152-CS2025-03-18
B502BSB9153CS0Cytokeratin Cocktail AE1 & AE3 Control SlidesBIO SB, INC.BSB-9153-CS2025-03-18
B502BSB9154CS0Cytokeratin HMW 34BE12 Control SlidesBIO SB, INC.BSB-9154-CS2025-03-18
B502BSB9156CS0Cytokeratin LMW CAM5.2 Control SlidesBIO SB, INC.BSB-9156-CS2025-03-18
B502BSB9158CS0Cytokeratin OSCAR Control SlidesBIO SB, INC.BSB-9158-CS2025-03-18
B502BSB9159CS0Cytokeratin MNF116 Control SlidesBIO SB, INC.BSB-9159-CS2025-03-18
B502BSB20550Cytokeratin 8&18 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB20620Cytokeratin LMW CAM5.2 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB27390Cytokeratin 19 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB28930Cytokeratin 16 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB53850Cytokeratin 19 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB53920Cytokeratin 20 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB53990Cytokeratin HMW 34BE12 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54060Cytokeratin 5 & 6 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54130Cytokeratin 7 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54200Cytokeratin 8 &18 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54270Cytokeratin 35BH11 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54340Cytokeratin Cocktail AE1 & AE3 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54410Cytokeratin LMW AE1 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB54480Cytokeratin HMW AE3 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB61830Cytokeratin OSCAR control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB67010Cytokeratin 18 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB67080Cytokeratin 20 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB61900Cytokeratin 17 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB62250Cytokeratin 14 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB65960Cytokeratin 4 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66030Cytokeratin 5 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66100Cytokeratin 5 & 6 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66310Cytokeratin 5 & 14 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66450Cytokeratin 6 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66520Cytokeratin 7 control slidesBIO SB, INC.Control Slides, 5 2020-06-01
B502BSB66660Cytokeratin 8 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66730Cytokeratin 10 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66800Cytokeratin 13 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66870Cytokeratin 14 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB66940Cytokeratin 15 control slidesBIO SB, INC.Control Slides, 52020-06-01
B502BSB35380Cytokeratin, MNF116 Control SlidesBIO SB, INC.Control Slides, 52020-10-30
B502BSB66170Cytokeratin 5 & ERG control slidesBIO SB, INC.Control Slides, 52020-08-31
B502BSB66590Cytokeratin 7 & CDX2 control slidesBIO SB, INC.Control Slides, 52020-08-31