Supply Of THROMBOPLASTIN + URINE KETONE STRIP in India

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Supply Of thromboplastin + urine ketone strip , thromboplastin ( prothrombin time ) reagent in 5 ml bottle ( 1 ml = 5 tests) , make : tulip, agappe, erba or similar , unit : (no= bot) ] , urine ketone strip: 1.strips should be used for semi-quantitative detection of keto nes in urine. 2. quantity: 50 tests/kit. 3. urine strips should be made of disposable plastic. 4. urin e strips should be supplied in a sealed canister along with a desiccant and should be ready to use. 5. each bottle should have a high quality colour chart for accurate analysis. 6. should ha ve a short interpretation time not more than 60 seconds. 7. storage temperature:15 degree cel sius to 30 degree celsius. 8. should have a shell life of minimum 18 months. 9. lot number and ex piry date should be? printed on the canister. 10. product literature should be submitted with e ach kit. 11. the manufacturers shall have a license issued by the competent authority defined u nder drugs and cosmetics act, 1940. 12. compliance to medical device rules (mdr) 2017 as amend ed till date and should have a valid medical device license for the product. 13. in case of impor ted kits it should be registered and licensed by the dcg(i). 14. iso 13485/ icmed 13485 or equivale nt certified manufacturer. 15. availability of test report from central govt/nabl/ilac accredited lab to prove the conformity to the declared specification. (proof of the same to be submitted). ]

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