Siemens ADVIA Centaur Intact PTH Reagent (iPTH)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SIEMENS HEALTHCARE PTE. LTD.

Class:

Class B IVD

Manufactured by:

Siemens Healthcare Diagnostics Inc

Therapeutic area:

Clinical chemistry

Therapeutic indications:

The ADVIA Centaur® Intact Parathyroid Hormone (PTH) reagent is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur CP, ADVIA Centaur XP and ADVIA Centaur XPT systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism or hypoparathyroidism. This assay can be used intra-operatively.

Product summary:

Models: ADVIA Centaur iPTH Reagent - 10492369 / 10492368, iPTH Calibrator - 10492394 / 10492387, ADVIA Centaur Multi-Diluent 11 - 05699280 (117228), Multi-Diluent 11 - 03479704 (111088), iPTH 1, 2, 3, quality control material - 10492378, iPTH Master Curve Material - 10492373, ADVIA Centaur® XP Immunoassay System - 078-A010-07, ADVIA Centaur CP System - 086-A002-01, 09662772 (10309710), ADVIA Centaur CP Test Definition Version 1.0.AD - 10819292, ADVIA Centaur CP Start up Kit - 01548911 (10309024), ADVIA Centaur CP Language Kit - 03251150 (10318578), ADVIA System Verification Kit (1 Pkt) - 04819584 (10361898), ADVIA Centaur Acid and Base reagent - 00497043 (10313526), ADVIA Centaur PTH assay (100 tests) - 10699154, ADVIA Centaur PTH assay (500 tests) - 10699155, ADVIA Centaur Wash 1 (2 x 1500 mL) - 01137199 (112351), ADVIA Centaur Wash 1 (2 x 2500 mL) - 03773025, ADVIA Centaur PTH Quality Control - 10699156, ADVIA Centaur PTH Master Curve Material (5 x 1 mL) - 10698597, ADVIA Centaur Multi-Diluent 13 - 10492364, ADVIA Centaur XP System - 078-A011-03, ADVIA Centaur XPT System - 10711433, ADVIA Centaur® XP Immunoassay System - 078-A011-R03

Authorization date:

2012-12-28