Home › Device types › NJT
Immunohistochemistry Reagents And Kits
FDA product code NJT · Class 1 · Hematology
15,017
Registered devices
54
Adverse events
92
Recalls
0
510(k) clearances
Devices with this code
SV40 (MRQ-4) Mouse Monoclonal Antibody — CELL MARQUE CORPORATIONTissue-Tek Genie® — SAKURA FINETEK U.S.A., INC.CD45RO [UCHL-1] — BIOCARE MEDICAL LLCANTI-S-100 PROTEIN — BIOGENEX LABORATORIESDako — AGILENT TECHNOLOGIES SINGAPORE PTE LTDFLEX Mono Rb A-Hu p40, Clone DAK-p40, RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTDGenemed® — SAKURA FINETEK U.S.A., INC.Thermo Scientific — RICHARD-ALLAN SCIENTIFIC COMPANYMouse Monoclonal Anti-Human T-pit(MX102) Antibody — Fuzhou Maixin Biotech Co., Ltd.Gastrin RPab — BIO SB, INC.Tissue-Tek Genie® — SAKURA FINETEK U.S.A., INC.Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody — CELL MARQUE CORPORATIONKappa (EP171) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATIONIHC — Slmp, LLCDiagnostic BioSystems — Diagnostic Biosystems, Inc.Mouse Monoclonal Anti-Human CK19(MX054) Antibody — Fuzhou Maixin Biotech Co., Ltd.C1q, RPab — BIO SB, INC.MLH-1 — BIOCARE MEDICAL LLCp63 — BIOCARE MEDICAL LLCRabbit Monoclonal Anti-Human BRG1/SMARCA4(MXR028) Antibody — Fuzhou Maixin Biotech Co., Ltd.CD19 (EP169) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATIONMono Mo A-Thyroid Transcription Factor (TTF-1) Cl 8G7G3/1 — AGILENT TECHNOLOGIES, INC.Tinto p14 ARF, RMab — BIO SB, INC.Tinto Cytokeratin 14 (RM328) — 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.