Search Results
Found 2 results
510(k) Data Aggregation
K Number
K062615Device Name
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
Manufacturer
VISION BIOSYSTEMS INC.
Date Cleared
2007-01-29
(146 days)
Product Code
MXZ
Regulation Number
864.1860Why did this record match?
Applicant Name (Manufacturer) :
VISION BIOSYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.
PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Defection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.
Device Description
PGR Clone 16 is a monoclonal mouse antibody that detects a human progesterone receptor epitope located in the nucleus of PGR positive cells.
Ask a Question
K Number
K060227Device Name
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Manufacturer
VISION BIOSYSTEMS INC.
Date Cleared
2006-05-25
(115 days)
Product Code
MYA
Regulation Number
864.1860Why did this record match?
Applicant Name (Manufacturer) :
VISION BIOSYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) is intended for in vitro diagnostic use for the qualitative detection of estrogen receptor in routinely processed tissues. ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist.
Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.
ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Device Description
ER 6F11 is a monoclonal mouse antibody that detects a human estrogen receptor epitope located in the nucleus of ER positive cells.
Ask a Question
Page 1 of 1