FDA.reportPublic FDA data

Biological stain control IVD

Definition
A prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.
GUDID devices
402
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00613647020425FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.08-8012022-12-07
00613647020432FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.08-8022022-12-07
00816085020297Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-21
00816085020310Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085020440Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020457Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020464Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020471Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020488Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020495Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020501Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020518Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020525Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020532Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020549Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-11
00816085020556Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020563Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085020570Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-08-10
00816085020587Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-21
00816085020617Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816085023687Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-21
00816085023694Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-21
00816085023700Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-21
00816085023755Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-21
00816085024110Alpha-Tec SystemsAlpha-TEC Systems, Inc.02022-07-20
00816576028931Q-Slide™HARDY DIAGNOSTICSZ3012020-08-07
00819398026987QSlide™HARDY DIAGNOSTICSQS07002023-01-26
00819398028707Q-Slide™HARDY DIAGNOSTICSZ3022020-08-07
B502BSB9420CS0Tryptase Control SlidesBIO SB, INC.BSB-9420-CS2025-03-28
B502BSB0307CS05-Core Multi-Infectious Disease Cell Line Microarray Control SlidesBIO SB, INC.BSB-0307-CS2025-03-18
B502BSB0308CS02-Core SV-40 Cell Line Microarray Control SlidesBIO SB, INC.BSB-0308-CS2025-03-18
B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBIO SB, INC.BSB-0309-CS2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBIO SB, INC.BSB-0333-CS2025-03-18
B502BSB9007CS0Adipophilin/ADRP Control SlidesBIO SB, INC.BSB-9007-CS2025-03-18
B502BSB9011CS0Alpha Synuclein Control SlidesBIO SB, INC.BSB-9011-CS2025-03-18
B502BSB9017CS0Annexin A1 Control SlidesBIO SB, INC.BSB-9017-CS2025-03-18
B502BSB9018CS0Annexin VII Control SlidesBIO SB, INC.BSB-9018-CS2025-03-18
B502BSB9019CS0Arginase-1 Control SlidesBIO SB, INC.BSB-9019-CS2025-03-18
B502BSB9020CS0ARID1A Control SlidesBIO SB, INC.BSB-9020-CS2025-03-18
B502BSB9022CS0ATRX Control SlidesBIO SB, INC.BSB-9022-CS2025-03-18
B502BSB9023CS0Aurora B Control SlidesBIO SB, INC.BSB-9023-CS2025-03-18
B502BSB9024CS0B7H3/CD276 Control SlidesBIO SB, INC.BSB-9024-CS2025-03-18
B502BSB9025CS0BAP1 Control SlidesBIO SB, INC.BSB-9025-CS2025-03-18
B502BSB9032CS0BCOR Control SlidesBIO SB, INC.BSB-9032-CS2025-03-18
B502BSB9034CS0BG8 LewisY Control SlidesBIO SB, INC.BSB-9034-CS2025-03-18
B502BSB9035CS0BOB.1 Control SlidesBIO SB, INC.BSB-9035-CS2025-03-18
B502BSB9036CS0Brachyury Control SlidesBIO SB, INC.BSB-9036-CS2025-03-18
B502BSB9037CS0BRAF V600E Control SlidesBIO SB, INC.BSB-9037-CS2025-03-18
B502BSB9038CS0BRG-1/SMARCA4 Control SlidesBIO SB, INC.BSB-9038-CS2025-03-18
B502BSB9039CS0c-Met/HGFR Control SlidesBIO SB, INC.BSB-9039-CS2025-03-18
B502BSB9040CS0c-Myc Control SlidesBIO SB, INC.BSB-9040-CS2025-03-18
B502BSB9043CS0C3d Control SlidesBIO SB, INC.BSB-9043-CS2025-03-18
B502BSB9045CS0C4d Control SlidesBIO SB, INC.BSB-9045-CS2025-03-18
B502BSB9050CS0Cadherin17/LI-Cadherin Control SlidesBIO SB, INC.BSB-9050-CS2025-03-18
B502BSB9057CS0Caveolin-1 Control SlidesBIO SB, INC.BSB-9057-CS2025-03-18
B502BSB9119CS0Claudin-1 Control SlidesBIO SB, INC.BSB-9119-CS2025-03-18
B502BSB9120CS0Claudin-5 Control SlidesBIO SB, INC.BSB-9120-CS2025-03-18
B502BSB9121CS0Claudin-7 Control SlidesBIO SB, INC.BSB-9121-CS2025-03-18
B502BSB9122CS0Clusterin/Apolipoprotein J Control SlidesBIO SB, INC.BSB-9122-CS2025-03-18
B502BSB9126CS0CXCL12/SDF-1 Control SlidesBIO SB, INC.BSB-9126-CS2025-03-18
B502BSB9129CS0Cyclin B1 Control SlidesBIO SB, INC.BSB-9129-CS2025-03-18
B502BSB9131CS0Cyclin E1 Control SlidesBIO SB, INC.BSB-9131-CS2025-03-18
B502BSB9160CS0Cytomegalovirus Control SlidesBIO SB, INC.BSB-9160-CS2025-03-18
B502BSB9163CS0DOG-1 Control SlidesBIO SB, INC.BSB-9163-CS2025-03-18
B502BSB9170CS0Epstein Barr Virus LMP-1 Control SlidesBIO SB, INC.BSB-9170-CS2025-03-18
B502BSB9171CS0ERCC1 Control SlidesBIO SB, INC.BSB-9171-CS2025-03-18
B502BSB9172CS0ERG Control SlidesBIO SB, INC.BSB-9172-CS2025-03-18
B502BSB9178CS0FGFR-3 Control SlidesBIO SB, INC.BSB-9178-CS2025-03-18
B502BSB9180CS0Fli-1 Control SlidesBIO SB, INC.BSB-9180-CS2025-03-18
B502BSB9183CS0FOXL2 Control SlidesBIO SB, INC.BSB-9183-CS2025-03-18
B502BSB9184CS0FOXO1 Control SlidesBIO SB, INC.BSB-9184-CS2025-03-18
B502BSB9185CS0FOXP1 Control SlidesBIO SB, INC.BSB-9185-CS2025-03-18
B502BSB9186CS0FOXP3 Control SlidesBIO SB, INC.BSB-9186-CS2025-03-18
B502BSB9188CS0Fumarate Hydratase/Fumarase Control SlidesBIO SB, INC.BSB-9188-CS2025-03-18
B502BSB9189CS0GAB1/GRB2-associated-binding protein 1 Control SlidesBIO SB, INC.BSB-9189-CS2025-03-18
B502BSB9192CS0GATA3 Control SlidesBIO SB, INC.BSB-9192-CS2025-03-18
B502BSB9197CS0GLUT1 Control SlidesBIO SB, INC.BSB-9197-CS2025-03-18
B502BSB9198CS0Glutamine Synthetase Control SlidesBIO SB, INC.BSB-9198-CS2025-03-18
B502BSB9200CS0Glypican-3 Control SlidesBIO SB, INC.BSB-9200-CS2025-03-18
B502BSB9204CS0HEG1 Control SlidesBIO SB, INC.BSB-9204-CS2025-03-18