In re Tara Clinical Systems (CAAR Mumbai)
CAAR held that that the products in question i.e. ‘QDx Instacheck™ PCT’ with reader ‘QDx Instacheck™’ as a kit merit classification under CTH 3822, more specifically under CTI 3822 9090 of the First Schedule to the Customs Tariff Act, 1975 and the said products are covered under entry at Sr. No. 80 of Schedule-II of Notification No. 1/2017-IGST (Rate) dated 28th June 2017
FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, MUMBAI
M/s. Lara Clinical Systems, (having IEC No. AALFT6504F and hereinafter referred to as ‘the applicant’, in short) hied two applications (CAAR-l) for advance ruling before the Customs Authority for Advance Rulings, Mumbai (CAAR in short). The said applications were received in the secretariat of the CAAR, Mumbai on 26.06.2023 along with enclosures in terms of Section 2811 (I) of the Customs Act, 1962 (hereinafter referred to as the ‘Act’ also). The applicant is seeking advance ruling on the classification “QDx Instacheck™ PCT” with reader “QDx Instacheck™” as a kit and the applicable IGST rate leviable under sub-section (7) of Section 3 of the Customs Tariff Act, 1975 for imports.
2. Applicant has stated as follows in their statement of relevant facts having a bearing on the question(s) raised enclosed with the CAAR-1 application:
2.1. The applicant intends to import the reagent named “QDx Instachcek™ PCT” with reader “QDx Instacheck1M” as a kit i.e., the kit would be imported as one product having both the components i.e., the test cartridge and reader for diagnosis purpose. The kit is a fluorescence immunoassay for quantitative measurement of procalcitonin (PCT) concentration in human whole blood/scrum/plasma for diagnosis of bacterial infection and sepsis. It is for in vitro diagnostic use only. In vitro means elsewhere outside a living organism i.e., this kit is not placed or used inside a human being’s body and therefore, these diagnostic reagents are not designed to be administered to the patients. Immunoassays are bioanalytical methods in which the quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. One such immunoassay method is used in the product in question for diagnosis.
2.2. The reagent “QDx Instachcek™ PCT” works with the reader “QDx Instachcek™”. The components of QDx Instachcek™ PCT consists of the following:
