Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits

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Description

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 Serum
Type of Test Qualitative
Testing Principle Lateral flow chromatographic immunoassay
Result Time (min) 10-20
Ability to Evaluate Negative or Positive test result Yes
Sensitivity (%) 99 percent
Specificity (%) 98 percent
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, 1940 and applicable rules there under Yes

KIT CONTENTS

Main items in test kit for performing the test 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, components, methodologies, validity criteria, performance characteristics,bio-safety, limitations of assay, storage condition, manufacturing 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
Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kit Yes
Other accessories and spares provided if any for standard pack in the kit STANDARD MATERIAL

PACKAGING

Pack Size 50 Tests Pack
The packing and labelling should be as per Drugs and Cosmetics Act, 1940 and applicable rules there under Yes
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) NA for domestically manufactured kits
Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 Yes
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 Number 743-BH
Drug License Date 22.05.15
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) GMP,WHO GMP
GMP/ WHO GMP Certification Number 6402
GMP/ WHO GMP Certification Date 05.02.18
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 certified 3346
Certificatiion Number 6402
Certificatiion Date 05.02.18
Certification Issuing Authority UK 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 body National Insitute of Biological Sciences
Name of the Performance Evaluation Report issuing body if other than specified institute FDA

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 consignee Yes

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