Corrigendum Rate Contract Bl in MANDAWAR - Complete Tender Details

Corrigendum : Rate Contract Blood Bank Department Kits/reatents/consuamble Items At Srg Hosptial Jhalawar - Blood Grouping Antisera * Avidity & Titer: Must Have High Titer, Fast Agglutination (5–10 Seconds), And Include Corresponding Rh Control For Anti-d. * Approvals & Cold Chain: Must Be Cdsco Approved And Iso 13485 Certified, With At Least 80% Remaining Shelf Life And Strict 2°c To 8°c Cold Chain Transport. * Rejection Clause: Any Substandard Batch Showing Weak Reactions Will Be Rejected And Replaced By The Vendor At Their Own Cost Within 7 Days., Anti A Blood Grouping (anti A Monoclonal Serum) -10 Ml, Anti Ab Antisera -1x10 Ml, Anti B Blood Grouping (anti B Monoclonal Serum) -10 Ml, Anti D (rn) Blood Grouping Serum -10 Ml, Anti A1 Lectin -1x10 Ml, Anti H Lectin -1x10 Ml, Adhesive Plaster 4 Inch Wide, Band Aid Adhesive Strip, Blood Weighing Scale (0-1 Kg), Weighing Scale (digital), Weighing Scale (analog Spring Model), Bovine Albumin -1x10 Ml, Coombs Antisera -1x10 Ml, Blood Bags* Specifications For All The Below Blood Bags:general Specification: (should Meet Technical Specification As Specified In Minutes Of Technical Specification Committee To Review Specifications Of Blood Bags For The Use In Blood Banks Held On 15-02-2017 Under Ministry Of Health Govt Of India New Delhi) 33. Flexible Pre-sterilized 34. Pyrogen Free 35. Non-toxic, Non-haemolytic, Biocompatible Material 36. No Risk Of Contamination And Air Embolism (closed System) With All Leak Proof Seals (disposable Bags) 37. Slit On The Both Sides Of The Bags Should Be Enough To Accommodate 5 – 10 Ml Volume Test Tubes 38. The Capacity Of The Bag Should Be Enough To Prevent Any Ballooning/rupture Of The Bag From The Seam When It Is Filled Up With The Requisite Volume Of Blood Tubing Of Bag: 39. Flexible Non-kinking 40. Non-sticking 41. Transparent 42. Leak-proof 43. The Tubing Should Have Same Id/segment Number As That On The Bag 44. The Tubes Should Have Multiple Printed Id/segment Numbers Needle: 45. 16 Gauge Ultra-thin Walled And Straight 46. Sharp Regular Margins And Beveled Tip 47. Rust Proof 48. Tightly Fixed With Hub Covered With Sterile Guard 49. Hermetically Sealed External Port: 50. Tamper Proof And Shouldnt Be Re-capped 51. Easily Accessible Anticoagulant And Preservative Solution: 52. Cpda-1 (49 Ml I.e. 14 Ml/100 Ml Of Blood) In Collecting Bag 53. Sagm (100 Ml) In Satellite Bag 54. Clear & Colourless 55. No Discolouration On Storage At Room Temperature 56. Manufacturer To Supply Anticoagulant Quality Check Certificatelabel: 57. Non-peal Off, Heat Sealed Labels 58. Remain Attached Between Room Temperature To – 80 Degree C With A Transparent Adhesive 59. Date Of Manufacturing, Date Of Expiry And Lot Number Must Be Mentioned On Each Bag 60. The Expiry Date Should Be At Least 2 Years From The Date Of Supply Of Blood Bags To The Institute Resistance To Distortion: 61. 1. Filled To Normal Capacity Shall Withstand An Acceleration Of 5000g For 30 Min At Temperature 4°c To 24°c Without Becoming Permanently Distorted And Should Withstand Temperature Up To -80°c Without Breakage. Important: 62. Firm Should Comply With Iso 9002& Iso3826 Quality For Blood Bags And Provide Certificate 63. 31.the Manufacturer Or Authorized Distributor Will Enclose At The Time Of Supply The Complete Analysis Report On Form -39 For Each Batch From The Laboratory Duly Approved By The Govt. / State Drug Controller Of India And The Expenditure Incurred Shall Be Borne By The Manufactures / Authorized Distributor. 64. 32. The Manufacturers Should Have Supplied Blood Bags Continuously And Satisfactorily To Government Blood Banks For A Period Of 3 Years. List Of Such Government Blood Banks Should Be Enclosed. A Satisfactory Quality And Supply Certificate From Any Of The One Government Blood Banks Should Be Enclosed For Preceeding 3 Years, Blood Bags With Cpda 1-single (350 Ml.)*, Blood Bags With Cpda 1-double (350 Ml.)*, Double Blood Bag Sagm(350 Ml.), Double Blood Bag Sagm(450 Ml.)*, Blood Bags With Cpda1-double (450 Ml.)*, Blood Bags With Cpda1-triple(350 Ml.)*, Blood Bags With Cpda1 -triple(450 Ml.)*, Triple Sagm Blood Bags (450 Ml.)*, Triple Sagm Blood Bags(350 Ml.)*, Transfer Blood Bags (300ml.)*, Blood Bags (450ml.)with Pre Storage Leukocyte Reduction Filters, Blood Administration Set With Filter*(25nos.perpack), Rbc Leukocyte Reduction Filters(lab Side With Transfer Bag)- 3rd Generation, Blood Bags(350ml)with Prestorage Leukocyte Reduction Filters, Platelet Leukocyter Eduction Filters (lab Side With Transfer Bag)- 3rd Generation*, Platelet Leukocyter Eduction Filters (bedside)-3rd Generation, Paediatric Blood Bags With Cpda1 (100ml)*, Lancet, Multi Channel Tips (0.5-10 Ul-compatible) -1x1000, Multi Channel Tips (10-100 Ul-compatible) -1x1000, Multi Channel Tips (30-300 Ul-compatible) -1x1000, Multi Channel Tips (50-50 Ul- Compatible) -1x1000, Rpr/vdrl Test Kit-the Assay Should Be Calibrated To Who Refrence Serum And Same Should Be Supported By Statements In Kit Insert And Certificate From Manufacturer -the Test Should Be Able To Test Result Within 20 Minutes., Rubber Ball For Donor Use, Micro Tip Boxes 200-1000µl-auto Clavable, Micro Tip Boxes 2-200µl- Autoclavable, Weighing Machine (donor), Disposable Clean/yellow Tips For Micropipettes (2-200ul) -1x1000, Disposable Pink/blue Transparent Tips For Microplpettes (200-1000ul)- 1x1000, Finn Pipette Variable Volume (100-1000 Ul), Finn Pipette Variable Volume (10-100 Ul), Hbsag Elisa Test Kit 4th Gen. Hbsag Elisa Test Kits 13. Microplate Elisa Coated With Monoclonal Antibodies To Hbsag. 14. The Assay Should Be Able To Detect Surface Antigen To Hepatitis B Virus. 15. Adequate Documents Detailing The Principle, Components, Bio-safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provided With Each Kit. 16. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin. 17. In Case Of Imported Kits It Should Have Been Registered And Licensed In India By Dcg (i). 18. In Case Of Indigenous Manufacturers They Shall Have License Issued By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940, After Appropriate Evaluation By The Centers Approved By Dcg (i). 19. The Kit Should Have Minimum Shelf-life Of 60% Or 12 Months (whichever Is More) At The Port Of Discharge Of Consignees 20. The Assay Component Should Include Reactive And Non-reactive Controls. 21. The Assay Should Have Sensitivity Of More Than Or Equal To 99% And Specificity Of More Than Or Equal To 98%. 22. The Assay Should Have Analytical Sensitivity Of Detecting Less Than Or Equal To 0.5 Ng/ml. 23. The Manufacturer/authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°c 8°c. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-qualified By Who 24. The Kit Size Should Be 96 Tests/ Kit. Can Be Used On Any Manual/semi-automatic System Of Elisa. 1x96test, Hbsag Rapid Test Kit (rapid Test) 4th Gen. 12. Should Be Solid Phase/particle Coated With Monoclonal Antibodies To Hbsag. 13. The Assay Should Be Able To Detect Surface Antigen To Hepatitis B Virus 14. Adequate Documents Detailing The Principle, Components, Bio-safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provided With Each Kit. 15. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin 16. In Case Of Imported Kits It Should Be Registered And Licensed In India By Dcg (1). 17. In Case Of Indigenous Manufacturers They Should Be Licensed By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940, After Appropriate Evaluation By The Centers Approved By Dcg (i). 18. The Kit Should Have Minimum Shelf-life Of 60% Or 12 Months (whichever Is More) At The Port Of Discharge Of Consignees 19. The Total Procedure Time Shall Not Be More Than 30 Minutes 20. The Assay Should Have Sensitivity Of More Than Or Equal To 99% And Specificity Of More Than Or Equal To 98%. 21. The Assay Should Have Analytical Sensitivity Of Detecting Less Than Or Equal To 0.5 Ng/ml 22. The Manufacturer/authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°c 8°c. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-qualified By Who - Specimen : Serum/plasma, Finger Stick Whole Blood And Vein Puncture Whole Blood, Hcv Elisa Test Kit, ,4th Generation 11. Microplate Elisa Coated With Recombinant/synthetic Peptide Antigens For Core, Ns3, Ns4 And Ns5 And Antibody To Hcv Core Antigen. 12. Adequate Documents Detailing The Principle, Components, Bio-safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provided With Each Kit. 13. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin. 14. In Case Of Imported Kits It Should Have Been Registered And Licensed In India By Dcg (i). 15. In Case Of Indigenous Manufacturers They Shall Have License Issued By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940, After Appropriate Evaluation By The Centers Approved By Dcg(i). 16. The Kit Should Have Minimum Shelf-life Of 5/6th Or 12 Months (whichever Is More) At The Port Of Discharge Of Consignees. 17. The Assay Component Should Include Reactive (for Both Antibody And Antigen) And Non-reactive Controls. 18. The Assay Should Have A Sensitivity More Thanor Equal To 100% And Specificity Of More Than Or Equal To 98%. 19. The Manufacturer/authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2oc – 8oc. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-qualified By Who And Placed On Every Pack Of Kits. 20. The Pack Size Should Be 96 Tests/kit., Hcv Rapid Dot Test 4th Generation 10. Should Be Solid Phase/particle Coated With Recombinant And /or Synthetic Peptide Antigens For Core, Ns3, Ns4 And Ns5 11. Adequate Documents Detailing The Principle, Components, Bio-safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provided With Each Kit. 12. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin 13. In Case Of Imported Kits It Should Have Been Registered And Licensed In India By Dcg (i). 14. In Case Of Indigenous Manufacturers They Should Be Licensed By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940, After Appropriate Evaluation By The Centers Approved By Dcg (i). 15. The Kit Should Have Minimum Shelf-life Of 60% Or 12 Months (whichever Is More) At The Port Of Discharge Of Consignees 16. The Total Procedure Time Shall Not Be More Than 30 Minutes. 17. The Assay Should Have Sensitivity Of More Than Or Equal To 99% And Specificity Of More Than Or Equal To 98%. 18. The Manufacturer/authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°c 8°c. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-qualified By Who, Hiv Elisa (competitive) Test Kit Iv Generation 12. Should Be Solid Phase Micro Plate Coated Hiv I & Ii Recombinant And/or Synthetic Peptide Antigens And Antibody To Hiv 1 P 24. 13. The Assay Should Detect Hiv I And Ii Antibodies And Hiv I P 24 Antigen. 14. Adequate Documents Detailing The Principle, Components, Details Of Antigen For Antibody Detection Of Hiv 1 And 2 And P24 Antigen, Bio-safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provided With Each Kit. 15. The Kit Should Have Approval Of The Statutory Authority In Its Country Of Origin. 16. In Case Of Imported Kits It Should Be Registered And Licensed Under The Provisions Of Drugs & Cosmetics Act And Rules And/or Medical Devices Rules 2017 In India. 17. In Case Of Indigenous Manufacturers Should Be Licensed Under The Provisions Of Drugs & Cosmetics Act And Rules And Or Medical Devices Rules 2017 Issued By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940. 18. The Kit Should Have Minimum Remaining Shelf-life Of 5/6th Or 12 Months (whichever Is More) At The Port Of Discharge Of Consignees. 19. The Assay Component Should Include Reactive (for Both Antibody As Well As Antigen) And Non-reactive Controls With Each Kit. 20. The Assay Should Have Sensitivity Level Of 100% And Specificity Level Of More Than Or Equal To 98% 21. The Manufacturer/authorized Agent Should Ensure Maintenance Of Cold Chain During Storage And Transport The Kits At 2oc – 8oc. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-qualified By Sho And Placed On Every Pack Of Kits. 22. The Pack Size Should Be 96 Tests/kit., Hiv Rapid Dot Test (specification – 4th Generation 13. Should Be A Solid Phase Coated Hiv I & Hiv Ii Recombinant And /or Synthetic Peptide Antigens And Antibody To Hiv 1 P24. 14. The Assay Should Destec Hiv I And Ii Antibodies And Hiv 1p24 Antigen In Plasma, Serum Or Whole Blood. 15. Adequate Doccuments Detailing The Principle, Components, Details Of Antigen For Antibody Detection Of Hiv 1 And 1 And P24 Antigen, Biko-safety, Methodologiesm, Validity Criteria, Assays, Manufacturing & Expiry Dates Should Be Provide With Each Kit. 16. The Kit Should Have Approval Of The Statutory Authority From The Country Of Origin. 17. In Case Of Improtd Kits, It Should Be Registered And Licensed Under The Provisions Of Drugs & Conmetics Act And Rules And/or Medical Devices Rules 2017 In India. 18. In The Case Of Indigenous Manufactuers Should Be Licensed Under The Provisions Of Drugs & Cosmetics Act And Rules And/ Or Medical Devices Rules 2017 & Also Be Evaluated By The Centers Approved By Dcg(1). 19. The Kit Should Have Minimum Shelf-life Of 5/6 Or 12 Months (whichever Is More) At The Port Of Discharge Of Consignees. 20. The Time Required For Performing The Test Should Not Be More Than 30 Minutes. 21. The Control Dot/band Should Be Able To Detect The Presence Of Human Immunoglobulins And Should Not Be Just A Procedural Control Or Meant For Merely Checking The Flow Of Reagents Or Intergrity Of The Antigen. 22. The Assay Should Have Sensitivity Of 100% And Specificity Of More Than Or Equal To 98%. 23. The Manufacturers Should Ensure That : C. The Test Kits Should Be Packed Such That There Is A Provision To Conduct Single Test At A Time. D. The Assay Components Should Include Hiv Positive (both Antigern And Antibody Positive) And Negative Serum Control Sufficient For Conducting 20% Of The Tests (10% Negative And 10% Positive Controls): And 24. The Manufacture/authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2 Oc – 8o C The Cumulative Time Temperature Indicator Technology Used Should Be Pre-qualified By Who And Placed On Every Pack Of Kits., K-3 Edta Vial 1x100, K-2 Edta Vial 1x100, Microscope Slide Cover Slips, Microscope Slide, Test Tube Rack Stand For 18 Tubes, Test Tube Stand 48 Hole Plastic, Test Tube Stand 96 Hole Plastic, Plain Vial, Small Test Tube, Dropper, Graduated Flask And Beaker – 100ml., Graduated Flask And Beaker – 500ml., Graduated Flask And Beaker – 1000ml., Orange Juice 180ml., Orange Juice 250ml., Leukocyte Reduction Filter System For Red Blood Cells Features 1. Easy To Operate, Without Amendment User Habits. 2. Even At 4℃ Low Temperature, Puriblood Leukocyte Reduction Filter Still Have High Filtration Speed, High Leukocyte Filtration Efficacy, High Rbcs Recovery, And Low Hemolysis Ratio. 3. High Filtration Speed Can Applicable To Emergency Surgery Transfusion Requirements Needs. Specifications Capacity：1~2 Unit Blood (1 Unit = 250ml ) Flow Rate：approximately 50ml/min. Leukocytes Reduction Rate > 99.9% Rbcs Recovery Rate> 95% Application: Hospital Bedside, Direct Transfusion., Ice Pack Gel(400 Ml), Distlled Water 5 Ltr., Stand For Blood Grouping Antisera, Pf/pan Malaria Antigen Combo Rapid Diagnostic Test (rdt) Kit (targeting Hrp-ii For Plasmodium Falciparum And Pldh For Plasmodium Vivax / Pan-malaria Species) Suitable For Whole Blood Samples, With High Sensitivity (>95%), High Specificity, And Icmr/ce-ivd Approval, Ph Strips 0.0-6.0 Ph, Resolution:0.5ph Unit(50 Strips), Ph Strips 6.0-7.7 Ph, Resolution:0.3-0.4phunit(50 Strips), Ph Strips 7.0-14.0 Ph, Resolution:0.5ph Unit(50 Strips), Ph Buffer Capsules (3standard Buffers- Ph4 , Ph7 &ph 10)-2 Each, Specific Gravity Meter, Sodium Hypochlorite Solution 4%*(5litres Per Bottle), Copper Sulphate Cuso4.5 H2o-ar Grade*(500gms Per Pack), Microcuvette For Hemocue Hb301 Machine, Liss Coombs Gel Card Compatible With Bio Rad Id Gel Centrifuge Machine (288 Tests Per Pack), Abo/d+ Reverse Grouping Gel Card Compatible With Bio Rad Id Gel Centrifuge Machine, Liss Solution, Thermograph Chart Paper For Blood Bank Refrigerator(circular Chart 120gsm) For Haier Bbr, Chart Recorder Pen For Haier Bbr, Thermograph Chart Paper For Remi Pl 10 Ultra Platelets Incubator & Agitator, Chart Recorder Pen For Remi Pl 10 Ultra Platelets Incubator & Agitator, Syphilis Card Test, Flavoured Milk For Blood Donors(ilayachi/badam/kesar/rose), Hemoglobin Test Strips Compatible With Ozocheck Hemoglobin Analyzer