Immunohistochemistry Reagents And Kits
Hematology · 21 CFR 864.1860
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Recent MDR events
50 adverse event reports on file
- CONFIRM ANTI-CD34 (QBEND/10) MOUSE MONOCLONAL PRIMARY ANTIBODYJul 1, 2026MalfunctionVentana Medical Systems Inc.2028492-2026-02624
- ULTRAVIEW UNIVERSAL DAB DETECTION KITJun 29, 2026MalfunctionVentana Medical Systems Inc.2028492-2026-02600
- FLEX MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR CLONE EP1May 22, 2026InjuryAgilent Technologies, Inc0002916205-2026-00001
- VEN ANTI-HER2/NEU [4B5] RM PAB-US EXPORTApr 20, 2026MalfunctionVentana Medical Systems Inc.2028492-2026-01505
- ULTRAVIEW UNIVERSAL ALKALINE PHOSPHATASE RED DETECTION KITMar 23, 2026MalfunctionVentana Medical Systems Inc.2028492-2026-01035
- VENTANA HER2 DISH DNA PRB CKT-US EXPORTFeb 25, 2026MalfunctionVentana Medical Systems Inc.2028492-2026-00670
- VEN ANTI-HER2/NEU [4B5] RM PAB-US EXPORTDec 15, 2025InjuryVentana Medical Systems Inc.2028492-2025-05111
- ALK (D5F3)Aug 22, 2025MalfunctionVentana Medical Systems Inc.2028492-2025-02589
- VENTANA ANTI-P63 (4A4) MOUSE MONOCLONAL PRIMARY ANTIBODYJun 12, 2025MalfunctionVentana Medical Systems Inc.2028492-2025-01811
- CD45 (2B11 & PD7/26)May 19, 2025MalfunctionBio Sb, Inc3008773547-2025-00002
Event type breakdown
Recalls
92 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
MPOX Test
Distribution without premarket approval/clearance.
Z-0745-2026 · View FDA record ↗ - Agilent Technologies Denmark ApSOpen, ClassifiedSep 15, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Their is the potential for weak staining which may result in false negative CD20 identification.
Z-2563-2025 · View FDA record ↗ - Agilent Technologies Denmark ApSOpen, ClassifiedSep 15, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Their is the potential for weak staining which may result in false negative CD20 identification.
Z-2564-2025 · View FDA record ↗ - Agilent Technologies Denmark ApSOpen, ClassifiedSep 15, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Their is the potential for weak staining which may result in false negative CD20 identification.
Z-2565-2025 · View FDA record ↗ - Ventana Medical Systems, Inc.Open, ClassifiedAug 16, 2024
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Z-2644-2024 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-2996-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-2997-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-2998-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-2999-2018 · View FDA record ↗ - Ventana Medical Systems IncTerminatedSep 14, 2018
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3000-2018 · View FDA record ↗
Registered firms
46 firms currently registered for this product code
Sienna Cancer Diagnostics Limited
Melbourne Victoria, AU
Azer Scientific, Inc.
Morgantown, PA, US
Metamol Theranostics
Milford, OH, US
Wavesense, Inc.
Irvine, CA, US
Fuzhou Maixin Biotech Co., Ltd.
Fuzhou City Fujian, CN
Pathnsitu Biotechnologies Pvt Ltd
HYDERABAD Telangana, IN
Sakura Finetek U.s.a., Inc.
TORRANCE, CA, US
Proteintech Group Inc
Rosemont, IL, US
Life Technologies Corporation
FREDERICK, MD, US
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
Richard-allan Scientific Llc
KALAMAZOO, MI, US
Leica Biosystems Melbourne Pty Ltd
MELBOURNE Victoria, AU
Zeta Corporation
Monrovia, CA, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Cell Marque Corp.
Saint Louis, MO, US
Novascope Diagnostics Inc.
Zhubei Hsinchu (City), TW
Biocare Medical, Llc
Pacheco, CA, US
Shenzhen Dartmon Biotechnology Co., Ltd.
Shenzhen Guangdong, CN
Agilent Technologies, Inc.
CARPINTERIA, CA, US
Zhejiang Gene Science Co., Ltd
shaoxing Zhejiang, CN
Leica Biosystems Newcastle Ltd
NEWCASTLE UPON TYNE, GB
Ventana Medical Systems, Inc.
Tucson, AZ, US
Biogenex Laboratories Inc.
Fremont, CA, US
Biolegend, Inc.
San Diego, CA, US
Slmp Llc D.b.a. Statlab Medical Products
McKinney, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.