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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)
Nov 6, 2014Leica 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
NJTNone listed
Jun 4, 2014Leica 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
NJTNone listed
Jun 2, 2014Leica 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
NJTNone listed
Mar 21, 2014AMS Diagnostics, LLC
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Terminated
NJTNone listed
Mar 21, 2014AMS Diagnostics, LLC
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Terminated
NJTNone listed
Mar 21, 2014AMS Diagnostics, LLC
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Terminated
NJTNone listed
Jan 10, 2014Leica 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
NJTNone listed
Dec 13, 2012Leica 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
NJTNone listed
Apr 10, 2012Biocare 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
NJTNone listed
Mar 6, 2012Cell 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 22, 2012Lab 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
NJTNone listed
Feb 17, 2012Leica 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
NJTNone listed
Feb 17, 2012Leica 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
NJTNone listed
Feb 17, 2012Leica 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
NJTNone listed
Sep 9, 2011Leica 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
NJTNone listed
Sep 9, 2011Leica 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
NJTNone listed
Sep 9, 2011Leica 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
NJTNone listed
Aug 31, 2011Cell 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
NJTNone listed
Feb 9, 2011Leica 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
NJTNone listed
Sep 25, 2010Leica 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
NJTNone listed
Sep 25, 2010Leica 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
NJTNone listed
Sep 25, 2010Leica 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
NJTNone listed
Sep 15, 2010Lab 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
NJTNone listed
Dec 8, 2006Biogenex 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
NJTNone listed
Sep 23, 2006Biogenex Laboratories
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
Terminated
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed
Dec 23, 2005Dakocytomation 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
NJTNone listed

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