MERIL Serum Albumin Kit
Product Description
GENERAL FEATURES
| Product Description | Biochemistry Reagent Kits |
| Clinical Purpose | Biochemistry reagents kits are used in clinical settings to measure various substances in the blood or other bodily fluids, such as urine or cerebrospinal fluid. These measurements can provide important information about a patient's health status, as well as help diagnose and monitor various medical conditions |
PRODUCT INFORMATION
| Type of Test | Serum |
| Type of Reagent Kit | Albumin Kit |
| Detection Type | Quantitative |
| Testing Method | End Point Method |
| Reactivity | Human |
| Compatibility | Semi Automated Analyzers,Fully Automated Analyzers |
| Reagent should be liquid stable | Yes |
| State at room temperature | Liquid |
| Ready to use reagent kit | Yes |
| Calibrator & control to be provided | Yes |
| Linearity | 6 |
| Original kit literature in English/Hindi(not photocopy) should be provided with each kit | Yes |
| Storage Temperature | 2°C to 8°C |
| The supplier should ensure maintenance of recommended temperature during storage and transportation of Kit to the buyer | Yes |
PACKAGING
| Pack Size | 20 ml |
CERTIFICATIONS & REPORTS
| Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid drug license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes |
| Valid Drug License Number | MFG/MD/2018/000022 |
| Manufacturing unit certification | ISO:13485 (Latest) |
| Additional voluntary certification available | CM 5568-2017 |
| Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of Traceability certificate | Yes |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes |
SHELF LIFE
| Shelf life in months from the date of manufacture (when stored at recommended storage conditions) | 18 month |
| Minimum shelf life of the product at the time of delivery to the consignee | 3/4th of Total Shelf Life |
ADVANCE SAMPLE
| Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding | Yes |
ADDITIONAL REQUIREMENT
| Additional Requirement | NA |
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