Panels › Hematology › Product code NJT · Class 1
Immunohistochemistry Reagents And Kits
Regulation 864.1860
0510(k)s in 12 months (0 all time)
1recalls in 12 months (92 all time)
1recalls that name a 510(k)
Top companies in NJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Leica Microsystems, Inc. | 0 | 23 |
| Ventana Medical Systems Inc | 0 | 19 |
| Dakocytomation California Inc | 0 | 11 |
| Biocare Medical Llc | 0 | 9 |
| Lab Vision Corporation | 0 | 9 |
| Leica Biosystems Richmond Inc. | 0 | 7 |
| Cell Marque Corporation | 0 | 4 |
| Agilent Technologies Denmark ApS | 0 | 3 |
| AMS Diagnostics, LLC | 0 | 3 |
| Biogenex Laboratories | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB MPOX Test Open, Classified |
NJT | None listed |
| Sep 15, 2025 | Agilent Technologies Denmark ApS Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Model/Catalog Number: GA60461-2J
Software Version: Not applicable
Product Description: FLEX Monoclonal Mouse A Open, Classified |
NJT | None listed |
| Sep 15, 2025 | Agilent Technologies Denmark ApS Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Model/Catalog Number: GA60461-2CN
Software Version: Not applicable
Product Description: FLEX Monoclonal Mouse Open, Classified |
NJT | None listed |
| Sep 15, 2025 | Agilent Technologies Denmark ApS Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Model/Catalog Number: GA60461-2
Software Version: Not applicable
Product Description: FLEX Monoclonal Mouse An Open, Classified |
NJT | None listed |
| Aug 16, 2024 | Ventana Medical Systems, Inc. Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD Open, Classified |
NJT | None listed |
| Jul 30, 2021 | Leica Microsystems, Inc. BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 Terminated |
NJT | None listed |
| Jul 15, 2021 | Cell Marque Corporation Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 Open, Classified |
NJT | None listed |
| Nov 18, 2019 | Leica Microsystems, Inc. BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-li Open, Classified |
NJT | None listed |
| Oct 10, 2019 | Biocare Medical, LLC 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093.
For laboratory use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc iView DAB Detection Kit, Catalog Number 05266157001, model 760-091
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
NJT | None listed |
| Apr 24, 2018 | Biocare Medical, LLC Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S Terminated |
NJT | None listed |
| Mar 15, 2018 | Biocare Medical, LLC URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062A Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic Terminated |
NJT | None listed |
| Feb 27, 2018 | Ventana Medical Systems Inc OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the de Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients wit Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory us Terminated |
NJT | None listed |
| Jul 14, 2017 | Leica Biosystems Richmond Inc. Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD,
The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qua Terminated |
NJT | None listed |
| May 10, 2016 | Cell Marque Corporation SIOOA I (EP I84) Rabbit Monoclonal Antibody;
Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361.
Intended for identifying by light microscopy the presence of associated antigens in s Terminated |
NJT | K133845 |
| Apr 5, 2016 | Leica Microsystems, Inc. Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues. Terminated |
NJT | None listed |
| Apr 5, 2016 | Leica Microsystems, Inc. Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation Terminated |
NJT | None listed |
| Mar 31, 2016 | Biocare Medical, LLC Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit;
Catalog number M4U534L;
For In Vitro Use
Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conju Terminated |
NJT | None listed |
| Mar 22, 2016 | Leica Microsystems, Inc. Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566.
Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections. Terminated |
NJT | None listed |
| Feb 19, 2016 | Leica Microsystems, Inc. This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-em Terminated |
NJT | None listed |
| Feb 17, 2016 | Lab Vision Corporation CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each.
Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amou Terminated |
NJT | None listed |
| Feb 12, 2016 | Leica Microsystems, Inc. Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin Terminated |
NJT | None listed |
| Nov 25, 2015 | Leica Microsystems, Inc. Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by l Terminated |
NJT | None listed |
| Nov 9, 2015 | Biocare Medical, LLC Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same inte Terminated |
NJT | None listed |
| May 26, 2015 | Biocare Medical, LLC D2-40 (Lymphatic Marker); For In Vitro Diagnostic;
Catalog number: PM266AA
Product Usage:
In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative Terminated |
NJT | None listed |
| Apr 27, 2015 | Biocare Medical, LLC CD99
Catalog number PM008 AA;
For In Vitro Diagnostic Use.
Product Usage:
Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology metho Terminated |
NJT | None listed |
| Mar 24, 2015 | Leica Microsystems, Inc. Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining.
Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy Terminated |
NJT | None listed |
| Jan 13, 2015 | Biocare Medical Llc MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA;
Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of ly Terminated |
NJT | None listed |
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