ClearanceBrief
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)
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Top companies in NJT

DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
MPOX Test
Open, Classified
NJTNone listed
Sep 15, 2025Agilent 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
NJTNone listed
Sep 15, 2025Agilent 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
NJTNone listed
Sep 15, 2025Agilent 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
NJTNone listed
Aug 16, 2024Ventana Medical Systems, Inc.
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Open, Classified
NJTNone listed
Jul 30, 2021Leica Microsystems, Inc.
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Terminated
NJTNone listed
Jul 15, 2021Cell Marque Corporation
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Open, Classified
NJTNone listed
Nov 18, 2019Leica 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
NJTNone listed
Oct 10, 2019Biocare Medical, LLC
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Terminated
NJTNone listed
Sep 14, 2018Ventana 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
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Sep 14, 2018Ventana Medical Systems Inc
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
Terminated
NJTNone listed
Apr 24, 2018Biocare 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
NJTNone listed
Mar 15, 2018Biocare 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
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Terminated
NJTNone listed
Feb 27, 2018Ventana Medical Systems Inc
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
Terminated
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
Jul 14, 2017Leica 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
NJTNone listed
May 10, 2016Cell 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
NJTK133845
Apr 5, 2016Leica Microsystems, Inc.
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Terminated
NJTNone listed
Apr 5, 2016Leica 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
NJTNone listed
Mar 31, 2016Biocare 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
NJTNone listed
Mar 22, 2016Leica 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
NJTNone listed
Feb 19, 2016Leica 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
NJTNone listed
Feb 17, 2016Lab 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
NJTNone listed
Feb 12, 2016Leica 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
NJTNone listed
Nov 25, 2015Leica 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
NJTNone listed
Nov 9, 2015Biocare 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
NJTNone listed
May 26, 2015Biocare 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
NJTNone listed
Apr 27, 2015Biocare 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
NJTNone listed
Mar 24, 2015Leica 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
NJTNone listed
Jan 13, 2015Biocare 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
NJTNone listed

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