RequiredAnnual Turnover
RequiredOEM Authorization Certificate Bid to RA enabled No HCV (ELISA) Test Kits ( 9408 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) PRODUCT INFORMATION Type of Kit 4 th generation 4 th generation Detects Antibodies specific to Hepatitis C Virus * Detection Type Qualitative Qualitative
RequiredQuantitative Microplate ELISA Coated with recombinant and/or synthetic peptide antigens for core NS3
RequiredYes * 1/6 NS4 and NS5 Test can be performed on Whole Blood
RequiredSerum
RequiredPlasma Whole Blood
RequiredSerum
RequiredPlasma Assay Procedure Time (minutes) 90 90
Required120 The Assay should have sensitivity of ≥ 99 % and specificity of ≥ 98% Yes * The assay component should include reactive and non reactive control with each kit Yes * Storage temperature 2°C to 8°C * The supplier should ensure maintenance of cold chain during storage and transportation of Kits at 2°C to 8°C Yes * Cold Chain indicator provided with the kits Yes * A cumulative time/temperature indicator should indicate the exposure to temperature in the range of 2°C to 8°C Yes * The cumulative time temperature indicator technology used should be pre qualified by WHO Yes * Adequate documents 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 * The Kit Should be compatible to both semi automated and fully automated Elisa analyzers Yes * 2/6 The volume of all the chemicals used should be adequate enough for automated Elisa analyze Yes * The volume should cover the dead volume for automated ELISA system Yes * The kit should comply with all provisions of Drugs and cosmentics Act
Required1940 and applicable rules there under Yes * GENERAL FEATURES Product Description HCV ELISA Test Kit * Clinical Purpose To provide diagnosis of Hepatitis C virus infection * PACKAGING Pack Size 96 tests/kit 96 tests/kit The packing and labelling of the kit should be as per Drugs and Cosmetics Act
Required1940 and applicable rules there under Yes * CERTIFICATIONS & REPORTS The kit should have approval of the statutory authority in its country of origin Yes * The Kit is registered and licensed in India by DCGI in case of imported kits (Proof of the same to be submitted to buyer on demand) Yes * Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 NA for imported kits * 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) For sale or distribution * 3/6 Drug License Number - * Drug License Date - * Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) WHO GMP * GMP/WHO GMP Certification Number - * GMP/WHO GMP Certification Date - * 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) EU-CE (IVD)
RequiredUS-FDA 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 National Insitute of Biological Sciences National Insitute of Biological Sciences Name of the Performance Evaluation Report issuing body if other than specified - * 4/6 institute SHELF LIFE Shelf Life from the date of manufacture (in months) 24 36
Required24 The product should have atleast 3/4 of the total shelf life at the time of dispatch to the consignee Yes * * Bold specifications 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.
