Microgenics Alinity c Barbiturates

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Class:

Class B IVD

Manufactured by:

Microgenics Corporation

Therapeutic area:

Clinical toxicology

Therapeutic indications:

The Alinity c Barbiturates assay is used for the qualitative and semiquantitative determination of barbiturates in human urine on the Alinity c analyzer. The cutoff for the qualitative application is 200 ng/mL (0.840 μmol/L). The assay is intended for use in clinical laboratories. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Product summary:

Models: Alinity c DOA MC Qual Low Calibrator 1 Kit - 08P6301, Alinity c DOA MC Qual Calibrator 2 Kit - 08P6302, Alinity c DOA MC Semiquant Calibrator Kit - 08P6303, Alinity c DOA MC Negative Calibrator Kit - 08P6305, Alinity c DOA MC I Controls - 08P6310, Alinity c Barbiturates Reagent Kit - 09P5120, Alinity c Barbiturates Assay File - 09P51-1A, Alinity c Barbiturates Assay File - 09P51-3A, Alinity c DOA MC Negative Calibrator Kit - 08P6306, Alinity c DOA MC I Controls - 08P6318

Authorization date:

2020-02-24