Immunoassay Reagent Advia Centaur® Her-2/neu (H2n) CLIA Non-Waived For Advia Centaur Immunoassay System 50 Tests

Name: Immunoassay Reagent
Brand: Advia Centaur®

ANALYZER, CENTAUR HER-2/NEU D/S

McKesson #

1044516

Manufacturer #

915031

Brand

Advia Centaur®

Manufacturer

Siemens

Country of Origin

United States

Application

Immunoassay Reagent

CLIA Classification

CLIA Non-Waived

CLIA Classified

CLIA Non-Waived

For Use With

For Advia Centaur Immunoassay System

Form

Ready-to-Use Liquid

Number of Tests

50 Tests

Sample Type

Serum Sample

Specialty

Immunoassay

Test Category

Cancer Screening

Test Format

ReadyPack

Test Method

Two-site Sandwich Immunoassay

Test Name

Her-2/neu (H2n)

Test Type

Breast Cancer

UNSPSC Code

41115807

Volume

R1: 2.5 mL, R2: 12.5 mL, R3: 2.5 mL

For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems
HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than15 ng/mL
1 ReadyPack® primary reagent pack containing ADVIA Centaur HER-2/neu LITE Reagent, Solid Phase and Fluorescein Conjugate Reagent ADVIA Centaur HER-2/neu Master Curve card
1 ReadyPack® primary reagent pack containing ADVIA Centaur HER-2/neu LITE Reagent, Solid Phase and Fluorescein Conjugate Reagent ADVIA Centaur HER-2/neu Master Curve card