CERTIFICATE OF CONFORMITY

Transcription

1 TECHEUROPA INSPECTION AND CERTIFICATIONS PRIVATE LIMITED Website: CERTIFICATE OF CONFORMITY Manufacturer Jeev Diagnostics Private Limited #9, 5 th Floor, Gokul Tower, 9 & 10, C.P.Ramasamy Road, Alwarpet, Chennai Product Specifications identi Test Kits, I-Iis System Packs, I-chem System packs. (Detailed Product List Attached) Certificate Issue Date : Certificate Expiry Date : Certificate Number : CE.IN.IVD.1 Directive In-Vitro Diagnostic Complies with requirements applicable to the Directive 98/79/EEC The manufacturers Technical Documentation has been reviewed and found to comply with the requirements of Directive 98/79/EEC. Any Changes of the Medical Devices shall be immediately reported to Techeuropa Inspection and certifications Pvt. Ltd. in order to examine the validity of this certificate. Certificate confirms that the equipment complies with the Essential Safety Requirements and Objectives of Mentioned Directive / Standard. For Techeuropa Inspection And Certifications Private Limited. HEAD OF CERTIFICATION The certificate will remain current subject to the company maintaining its system to the required standard(s). This will be monitored regularly by Techeuropa Inspection And Certifications Private Limited. This certificate is the property of Techeuropa Inspection And Certifications Private Limited. This must not be copied in whole or part without the written permission of the Managing Director of Techeuropa Inspection And Certifications Private Limited. Deliberate misuse of the certificate or schedule will result in cancellation without notification. The product liability rests with the manufacturer or his representative in accordance with Council Directive 85/374/EEC.

2 Sl. No. Reagent Name Identi Test Kits 7A DIRECT HDL/LDL CALIBRATOR A DIRECT HDL/LDL CALIBRATOR TOTAL BILIRUBIN TEST KIT DIRECT BILIRUBIN TEST KIT TOTAL BILIRUBIN TEST KIT + DIRECT BILIRUBIN TEST KIT LDH -P TEST KIT GGT TEST KIT CK NAC TEST KIT CK MB TEST KIT AMYLASE TEST KIT MAGNESIUM TEST KIT UREA ENDPOINT TEST KIT HDL CHOL PPT KIT BILIRUBIN TOTAL TEST KIT BILIRUBIN DIRECT TEST KIT BILIRUBIN TOTAL TEST KIT+ BILIRUBIN DIRECT TEST KIT LDH-L TEST KIT CRP TEST KIT RF TEST KIT ASL(O) TEST KIT MICROALBUMIN TEST KIT HbA1c (IT) TEST KIT A HbA1c CALIBRATOR B HbA1c CONTROL 30168

3 Sl. No. Reagent Name Identi Test Kits 36 identi CHEMISTRY CONTROLS KIT / identi CHEMISTRY CALIBRATOR KIT identi CHEMISTRY CONTROLS PLUS IT / A enti CHEMISTRY CONTROLS PLUS KIT A CHOLESTEROL STANDARD A CREATININE STANDARD A TRIGLYCERIDES STANDARD A URIC ACID STANDARD A UREA STANDARD A ALBUMIN/TOTAL PROTEIN STANDARD A CALCIUM STANDARD A MAGNESIUM STANDARD A PHOSPHORUS STANDARD 30191

4 Sl. No. i-lis System Packs Parameter Name 16 BILIRUBIN TOTAL TEST KIT BILIRUBIN DIRECT TEST KIT LDH -P TEST KIT GGT TEST KIT CK NAC TEST KIT CK MB TEST KIT AMYLASE TEST KIT MAGNESIUM TEST KIT LDH-L TEST KIT 38504

5 Sl. No. i-chem/ i-chem 100/ i-chem 240 System Packs Parameter Name 16 BILIRUBIN TOTAL TEST KIT BILIRUBIN DIRECT TEST KIT LDH -P TEST KIT GGT TEST KIT CK NAC TEST KIT CK MB TEST KIT AMYLASE TEST KIT MAGNESIUM TEST KIT LDH-L TEST KIT 38504