Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits

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Description

GENERAL FEATURES

Product DescriptionHepatitis B Surface Antigen (HBsAg) Rapid Test Kits
Clinical PurposeTo provide diagnosis of Hepatitis B Virus infection

PRODUCT INFORMATION

DetectsHepatitis B Surface Antigen (HBsAg)
Should be solid phase/ particle coated with monoclonal antibodies to HBsAgYes
Test Should be able to detect all 11 subtype of HBsAgYes
Test can be performed onSerum
Type of TestQualitative
Testing PrincipleLateral flow chromatographic immunoassay
Result Time (min)10-20
Ability to Evaluate Negative or Positive test resultYes
Sensitivity (%)99 percent
Specificity (%)98 percent
Contains an internal control line/dot for the confirmation that the test has been performed correctlyYes
Storage temperature2°C to 30°C
The supplier should ensure maintenance of recommended temperature during storage and transportation of KitYes
The kit should comply with all provisions of Drugs and cosmentics Act, 1940 and applicable rules there underYes

KIT CONTENTS

Main items in test kit for performing the testCard
Sample Dropper Provided with each card/stripYes
Dessicant to absorb moisture so that the Card/Strip do not get spoiled provided with each cardYes
Sample Diluent/Assay Buffer ProvidedYes
Packaging insert in English detailing the principle, components, methodologies, validity criteria, performance characteristics,bio-safety, limitations of assay, storage condition, manufacturing and expiry dates and methods of disposal Provided with each kitYes
Reactive and non reactive controls provided with each kit in adequate volume (minimum 10% of pack size)No
Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kitYes
Other accessories and spares provided if any for standard pack in the kitSTANDARD MATERIAL

PACKAGING

Pack Size50 Tests Pack
The packing and labelling should be as per Drugs and Cosmetics Act, 1940 and applicable rules there underYes
Each card (cassette) should have space for patients particulars and date of the testYes
The test kit should be packed in such a way that there is proivision to conduct single test at a timeYes
Each test kit should be indivdually packed in a hermetically sealed and non-permeable pouchYes

CERTIFICATIONS & REPORTS

The kit should have approval of the statutory authority in its country of originYes
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)NA for domestically manufactured kits
Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940Yes
Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act, 1940 (Proof of the same to be submitted to buyer on demand)For Manufacture to sale,For sale or distribution
Drug License Number743-BH
Drug License Date22.05.15
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand)GMP,WHO GMP
GMP/ WHO GMP Certification Number6402
GMP/ WHO GMP Certification Date05.02.18
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 certified3346
Certificatiion Number6402
Certificatiion Date05.02.18
Certification Issuing AuthorityUK CERTIFICATION & INSPECTION LIMITED
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 bodyNational Insitute of Biological Sciences
Name of the Performance Evaluation Report issuing body if other than specified instituteFDA

SHELF LIFE

Shelf Life (in months)24
The product should not have passed more than 1/6 of the total shelf life at the time of dispatch to the consigneeYes

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