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New Application For Ruling
New Application For Ruling
CLASSIFICATION RULING
1.) Name and address of Applicant : JAPLAN DIAGNOSTIC (PVT) LTD
NO 101, KANDY ROAD, KIRIBATHGODA
2.a) Full trade description of the ST AIA-PACK TSH is an immunological assay designed for
Commodity Diagnostic use only for the quantitative measurement of thyroid
stimulating hormones in human serum or heparinized plasma on
TOSOH AIA System Analyzers.
3.) What are their constituent Materials? Plastic test cups containing lyophilized twelve magnetic beads coated
with anti-TSH mouse monoclonal antibody and 50ul of anti-TSH
mouse monoclonal antibody (to human TSH) conjugated to bovine
alkaline phosphatase with sodium azide as a preservative.
4.) What is it used for : ST AIA-PACK TSH is a two-site immunoenzymometric assay which
is performed entirely in the AIA-PACK test cups. TSH present in the
test sample is bound with monoclonal antibody immobilized on
magnetic beads and monoclonal antibody conjugated with bovine
alkaline phosphatase in the AIA-PACK test cups. The magnetic beads
are wash to remove unbound enzyme- labeled monoclonal antibody
and are then incubated with a fluorogenic substrate, 4-
methylumbelliferyl phosphate (4-MUP). The amount of enzyme
conjugated with monoclonal antibody that binds to the beads is
directly promotional to the TSH concentration in the test sample.
5.) In what form is it imported? Freeze dried lyophilized immunological material in a plastic test cup.
One box contains 100 TSH test cups.
6.) Manufacturer's or supplier's name & Tosoh Corporation, Shiba-koen First Bidg. 3-8-2 Shiba, Minato-ku,
address: Tokyo 105-8623, Japan
7.) Additional Information or comments: -