Abbott AxSYM Testosterone Assay (LN 3C85 and 3K43)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Class:

Class B IVD

Manufactured by:

Abbott GmbH & Co. KG

Therapeutic area:

Immunology

Therapeutic indications:

AxSYM Testosterone is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System.

Product summary:

Models: AxSYM Testosterone Standard Calibrators - 3C85-01, AxSYM Testosterone Assay Disk - 3K43-01, Abbott AxSYM Systems - 7A83-27, Abbott AxSYM Systems - 7A83-29, Abbott AxSYM Systems - 7A83-28, Abbott AxSYM Systems - 7A83-79, Abbott AxSYM Systems - 7A83-80, Abbott AxSYM Systems - 7A83-85, Abbott AxSYM Systems - 7A83-86, Abbott AxSYM Systems - 7A83-95, Abbott AxSYM Systems - 7A83-98, AxSYM MEIA Optic Standard - 9A22-01, AxSYM FPIA Optical Standard - 9A23-01, AxSYM System Software (LS 120), Version 5.0 - 4J76-01, AxSYM System Software (LS 120), Version 5.10 - 4J76-02, AxSYM System Software (LS 120), Version 5.20 - 4J76-04, AxSYM System Software (Compact Flash), Version 5.20 - 4J76-05, AxSYM System Software (LS 120), AxSYM Version 6.0 - 4J76-09, AxSYM System Software (Compact Flash), Version 6.0 - 4J76-10, AxSYM System Software (LS 120), AxSYM Version 6.10 - 4J76-12, AxSYM System Software (Compact Flash), Version 6.10 - 4J76-13, AxSYM System Software (LS 120), AxSYM Version 6.20 - 4J76-14, AxSYM System Software (Compact Flash), Version 6.20 - 4J76-15, AxSYM System Software (LS-120), Version 6.30 - 4J76-16, AxSYM System Software (Compact Flash), Version 6.30 - 4J76-17, AxSYM System Software Version 4.01 - 8G60-02, AxSYM System Software Version 4.02 - 4J80-01, AxSYM Matrix Cells - 8A73-01, AxSYM Matrix Cells - 8A73-02, AxSYM Reaction Vessels - 8A75-01, AxSYM Reaction Vessels - 8A75-02, AxSYM Sample Cups - 8A76-01, AxSYM Tubing Decon Solution - 7B05-09, AxSYM Probe Cleaning Solution - 9A35-05, AxSYM Solution 4 Line Diluent - 8A46-01, AxSYM Solution 4 Line Diluent - 8A46-02, AxSYM Solution 1 MUP - 8A47-04, AxSYM Solution 3 Matrix Cell Wash - 8A81-04, AxSYM Testosterone Reagent Pack - 3C85-20

Authorization date:

2011-05-25