CINtec® Histology

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DIAGNOSTICS F. Hoffmann-La Roche Ltd

CINtec® Histology (250-test)

Positive CINtec® Histology status of a cervical biopsy specimen using the OptiView DAB Detection Kit on the VENTANA BenchMark ULTRA IHC/ISH instrument
Catalog Number:725-4793
Ordering Code:06680011001
Quantity:250 tests
Controls:Cervical Carcinoma, CIN2, CIN3, Normal Cervix
Clone Name:E6H4™
Species:Mouse Monoclonal
Regulatory Status:IVD

CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument.

The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN).

Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.

Intended for in vitro diagnostic (IVD) use. Prescription Use Only.

The trademarks CINtec®, mtm laboratories and E6H4™ are the sole property of Roche mtm laboratories AG and may not be used without prior written consent from Roche mtm laboratories AG.

The CINtec® E6H4 p16 clone and CINtec® Histology products are based on proprietary technology owned by or licensed to Roche, which is protected by national and international intellectual property rights including European Patent EP 1 092 155 (incl. DE, UK, FR, ES, IT, BE, CH, DK, FI, GR, IE, LU, NL & SE) and U.S. Patents US 6,709,832 & US 7,425,617, as well as further national patents.

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