RequiredExperience with Government
RequiredAnnual Turnover
RequiredCertificate (Requested in ATC)
RequiredOEM Authorization Certificate
RequiredOEM Annual Turnover Bid to RA enabled No Note: 1. OEM Turn Over Criteria: The minimum average annual financial turnover of the OEM of the offered product during the last three years
Requiredending on 31st March of the previous financial year
Requiredshould be as indicated in the bid document. Documentary evidence in the form of certified Audited Balance Sheets of relevant periods or a certificate from the Chartered Accountant/Cost Accountant indicating the turnover details for the relevant period shall be uploaded with the bid. In case the date of constitution/incorporation of the OEM is less than 3 year old
Requiredthe average turnover in respect of the completed financial years after the date of constitution shall be taken into account for this criteria. Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits ( 47219 pieces ) Technical Specifications 1/6 * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits * Clinical Purpose To provide diagnosis of Hepatitis B Virus infection * PRODUCT INFORMATION Detects Hepatitis B Surface Antigen (HBsAg) * Should be solid phase particle coated with monoclonal antibodies to HBsAg Yes * Test Should be able to detect all 11 subtype of HBsAg Yes * Test can be performed on Whole Blood Whole Blood
RequiredSerum
RequiredPlasma Type of Test Qualitative Qualitative
RequiredQuantitative Testing Principle Lateral flow chromatographic immunoassay Lateral flow chromatographic immunoassay
RequiredImmunofiltration Result Time (min) 10-20 * Ability to Evaluate Negative or Positive test result Yes * Sensitivity (%) 99 * Specificity (%) 99 * Contains an internal control line/dot for the confirmation that the test has been performed correctly Yes * Storage temperature 2°C to 30°C * The supplier should ensure maintenance of recommended temperature during storage and transportation of Kit Yes * The kit should comply with all provisions of Drugs and cosmentics Act
Required1940 and Yes * 2/6 applicable rules there under KIT CONTENTS Main items in test kit for performing the test Card Card Sample Dropper Provided with each card/strip Yes * Dessicant to absorb moisture so that the Card/Strip do not get spoiled provided with each card Yes * Sample Diluent/Assay Buffer Provided Yes * Packaging insert in English detailing the principle
Requiredcomponents
Requiredmethodologies
Requiredvalidity criteria
Requiredperformance c haracteristics
Requiredbio- safety
Requiredlimitations of assay
Requiredstorage condition
Requiredmanufacturing and expiry dates and methods of disposal Provided with each kit Yes * Reactive and non reactive controls provided with each kit in adequate volume (minimum 10% of pack size) No No Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kit No No Other accessories and spares provided if any for standard pack in the kit - * PACKAGING Pack Size 10 Tests Pack * The packing and labelling should be as per Drugs and Cosmetics Act
Required1940 and applicable rules there under Yes * 3/6 Each card (cassette) should have space for patients particulars and date of the test Yes * The test kit should be packed in such a way that there is proivision to conduct single test at a time Yes * Each test kit should be indivdually packed in a hermetically sealed and non-permeable pouch Yes * CERTIFICATIONS & REPORTS The kit should have approval of the statutory authority in its country of origin Yes * The Kit should be registered and licensed in India by DCGI in case of imported kits (Proof of the same to be submitted to buyer on demand) - * Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 - * Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act
Required1940 (Proof of the same to be submitted to buyer on demand) - * Drug License Number - * Drug License Date - * Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) - * GMP/WHO GMP Certification Number - * GMP/WHO GMP Certification Date - * 4/6 ISO 13485 Certified Manufacturer (Proof of the same to be submitted to buyer on demand) Yes * Product Certifications (Proof of the same to be submitted to buyer on demand) EU-CE (IVD) * Four digit number of notified body If product is EU-CE certified - * Certificatiion Number - * Certificatiion Date - * Certification Issuing Authority - * 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 to the buyer on demand) Yes * Availability of Performance Evaluation Report (Proof of the same to be submitted to the buyer on demand) Yes * Performance Evaluation Report issuing body Any other govt approved lab * Name of the Performance Evaluation Report issuing body if other than specified institute - * SHELF LIFE Shelf Life (in months) 30 30 The product should not have passed more than 1/6 of the total shelf life at the time of dispatch to the consignee Yes * * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
