FoR. epublic of the Philippines a Department of Health FBA “a FOOD AND DRUG ADMINISTRATION «Pe earraene A 15MM216) Registration Status RENEWAL FDA Registration No. RR-1123 Classification CERTIFICATE OF PRODUCT REGISTRATION Pursuant t0 the provisions of Republic Act (R.A.) No. 1720 as amended, known as the Foods, Drugs. Device end Cosmetics Act, the product more particularly described hereunder has been found to conform with the standards and have complied with the rules and regulations governing the registration of diagnostic reagents Name of Product : EPICLONE™ ANTI-A MURINE MONOCLONAL BLOOD GROUPING REAGENT Code: 0261 Manufacturer Bio CSL Pry. Ltd, - Parkville Victoria, Australia Trader Importer Medical Center Trading Corporation - Shaw Bvd., Pasig City Distributor : Medical Center Trading Corporation - Shaw Bivd., Pasig City Approved Use + For determining blood groups of human serum. To detect A antigen present on the surface of human red cells, : Claimed Shelf-Life +30 months Storage Condition + 2-8C Packaging Om! viel This registration shall be valid for five year(s) and shall expire on 3 October 2018 subject to the conditions Ksted on the reverse side, No change in the information, labelling and commercial presentation of this product shall be made during the effectivity of this registration without epproval of this Office, This registration is subject to suspension, cancellation or recall should violation of any pro\ nis su ians of R.A. 3720, as amended, and/or regulations issued thereunder involving the product be committed. 2 Witness My Hand and Seal of this Office, this 10th day of August, 2016. BY AUTHORITY OF THE SECRETARY OF HEALTH rbot, ENGR. BAYANIC. SANJUAN, MSc, MNSA Offfcer-in-Charge RSN:BHDT-R-2013-3065 Mn A OR.No 10478302 / 0549570 0729883 Me. Bote Amount 6,060.00 / 1,520.00 ) $10.00 Date Issued 515 August 2013 /15 April 2014 /23 June 2016 JCRMTILSA 28 Bed <0 esautes — ztt@z sTaz/sa/eT