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) |
|---|---|---|---|
| Nov 6, 2014 | Leica Microsystems, Inc. Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a pre Terminated |
NJT | None listed |
| Jun 4, 2014 | Leica Microsystems, Inc. Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use. Terminated |
NJT | None listed |
| Jun 2, 2014 | Leica Microsystems, Inc. Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use. Terminated |
NJT | None listed |
| Mar 21, 2014 | AMS Diagnostics, LLC AMS AST For the In vitro quantitative determination of AST in serum
Quantitative determination of AST in serum. Terminated |
NJT | None listed |
| Mar 21, 2014 | AMS Diagnostics, LLC AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum
Quantitative determination of Uric Acid in serum. Terminated |
NJT | None listed |
| Mar 21, 2014 | AMS Diagnostics, LLC AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum
Quantitative determination of Bun in serum. Terminated |
NJT | None listed |
| Jan 10, 2014 | Leica Biosystems Newcastle Ltd. Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.Leic Terminated |
NJT | None listed |
| Dec 13, 2012 | Leica Microsystems, Inc. Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Terminated |
NJT | None listed |
| Apr 10, 2012 | Biocare Medical Llc BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520.
V Terminated |
NJT | None listed |
| Mar 6, 2012 | Cell Marque Corporation Cell Marque CD7 (MRQ-12);
Mouse Monoclonal Antibody,
Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label.
Cell Marque, Rocklin, CA Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation Streptavidin Alkaline Phosphatase (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect specific antibodies bound to an an Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Detection System;
Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect speci Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Plus Large Volume Detection System;
Anti-Polyvalent, Alk-Phos (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Large Volume Detection System;
Anti-Polyvalent, Alk-Phos (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Plus Detection System;
Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detec Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Detection System;
Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect spe Terminated |
NJT | None listed |
| Feb 22, 2012 | Lab Vision Corporation UltraVision Detection System;
Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to Use)
Manufactured by: Lab Vision Corporation
46360 Fremont Blvd, Fremont, CA 94538
Product Usage: These products detect spe Terminated |
NJT | None listed |
| Feb 17, 2012 | Leica Microsystems, Inc. Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell ori Terminated |
NJT | None listed |
| Feb 17, 2012 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the classification of tumors of T-cell origi Terminated |
NJT | None listed |
| Feb 17, 2012 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part of an antibody panel for the characterization of T cell disorders; Catalog No. Terminated |
NJT | None listed |
| Sep 9, 2011 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Bal Terminated |
NJT | None listed |
| Sep 9, 2011 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West Terminated |
NJT | None listed |
| Sep 9, 2011 | Leica Microsystems, Inc. Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Be Terminated |
NJT | None listed |
| Aug 31, 2011 | Cell Marque Corporation Cell Marque antibody CD99 (H036-1.1)
Mouse Monoclonal Antibody.
Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677
The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified l Terminated |
NJT | None listed |
| Feb 9, 2011 | Leica Microsystems, Inc. Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800;
Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Terminated |
NJT | None listed |
| Sep 25, 2010 | Leica Microsystems, Inc. Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue culture supernatant in a 1 mL vial; an in vitro diagnostic reagent for the qualitative identification by light micro Terminated |
NJT | None listed |
| Sep 25, 2010 | Leica Microsystems, Inc. Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized tissue culture supernatant in vials; an in vitro diagnostic reagent for the qualitative identification Terminated |
NJT | None listed |
| Sep 25, 2010 | Leica Microsystems, Inc. Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of human thyroid transcripti Terminated |
NJT | None listed |
| Sep 15, 2010 | Lab Vision Corporation NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of Terminated |
NJT | None listed |
| Dec 8, 2006 | Biogenex Laboratories Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA. Terminated |
NJT | None listed |
| Sep 23, 2006 | Biogenex Laboratories Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4011 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4010 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4009 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4008 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4007 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4005 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4003 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4002 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001 Terminated |
NJT | None listed |
| Dec 23, 2005 | Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000 Terminated |
NJT | None listed |
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