Search Results
Found 1 results
510(k) Data Aggregation
K Number
K103818Device Name
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
Manufacturer
VENTANA MEDICAL SYTEMS, INC
Date Cleared
2011-11-16
(322 days)
Product Code
MXZ
Regulation Number
864.1860Why did this record match?
Applicant Name (Manufacturer) :
VENTANA MEDICAL SYTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This antibody is intended for in vitro diagnostic (IVD) use. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PR positive normal and neoplastic cells. CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. Prescription use only.
Device Description
Ventana's CONFIRM anti-Progesterone Receptor (1E2) Rabbit Monoclonal Primary Antibody specifically binds to progesterone receptor antigen located in the nuclear region of a variety of normal and neoplastic tissues. The antibody is diluted in 0.05 M Tris-HCl with 2% carrier protein, and 0.1% ProClin 300, a preservative. There is trace (0.2%) fetal calf serum of U.S. origin from the stock solution. Total protein concentration of the reagent is approximately 10 mg/mL. Specific antibody concentration is approximately 1 µg/mL. CONFIRM anti-PR (1E2) is a rabbit monoclonal antibody produced as a cell culture supernatant.
Ask a Question
Page 1 of 1