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Immunohistochemistry Reagents And Kits
FDA product code NJT · Class 1 · Hematology
12,544
Registered devices
50
Adverse events
92
Recalls
0
510(k) clearances
Devices with this code
P504s (13H4) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATIONCD14 (EPR3653) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATIONPAX-8 (MRQ-50) Mouse Monoclonal Antibody — CELL MARQUE CORPORATIONFLEX Negative Control Rb Immunoglobulin RTU — AGILENT TECHNOLOGIES, INC.IgD Rabbit Polyclonal Antibody — CELL MARQUE CORPORATIONBOND — LEICA BIOSYSTEMS NEWCASTLE LTDPAX8 (M) — BIOCARE MEDICAL LLCANTI-MYOSIN — BIOGENEX LABORATORIESIHC — Slmp, LLCANTI-CD45 (LCA) — BIOGENEX LABORATORIESHuman Placental Lactogen (hPL) Rabbit Polyclonal Antibody — CELL MARQUE CORPORATIONMono Mo A-Hu Calponin Cl CALP — AGILENT TECHNOLOGIES, INC.BOND — LEICA BIOSYSTEMS NEWCASTLE LTDAlpha-Fetoprotein RMab — BIO SB, INC.h-Caldesmon (hHCD) Mouse Monoclonal Antibody — CELL MARQUE CORPORATIONFascin (55k-2) Mouse Monoclonal Antibody — CELL MARQUE CORPORATIONANTI-CD68 — BIOGENEX LABORATORIESFLEX Poly Rb A-Hu Kappa LC RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTDCytokeratin 5 (EP1601Y) + Cytokeratin 14 (LL002) Mouse and Rabbit Monoclonal Ant — CELL MARQUE CORPORATIONTinto TFF3 (BSB-181) — BIO SB, INC.Tinto Somatostatin Receptor 2/SSTR2 (EP149) — BIO SB, INC.SATB2 (RBT-SATB2) — BIO SB, INC.Tinto Desmin, MMab — BIO SB, INC.Tinto PU.1, RMab — BIO SB, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2024-06-27 | Ventana Medical Systems, Inc. | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. |
| 2021-07-30 | Leica Microsystems, Inc. | Product may not perform as specified in IFU. |
| 2021-07-15 | Cell Marque Corporation | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material per |
| 2019-11-18 | Leica Microsystems, Inc. | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. |
| 2019-10-10 | Biocare Medical, LLC | Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would |
| 2018-08-02 | Ventana Medical Systems Inc | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
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