Description
GENERAL FEATURES
| Product Description | Typhoid Rapid Test Kit |
| Clinical Purpose | To detect antibodies to Salmonella typhi in human serum or plasma |
| Detects | IgM Antibodies to salmonella typhi,IgG Antibodies to salmonella typhi |
| Type of Test | Qualitative |
| Testing Principle | Immuno-chromatographic Principle |
| Specimen Required for testing | Plasma |
| Result Time (min) | 15-20 |
| Ability to Evaluate Negative or Positive test result | Yes |
| Sensitivity (%) | 94.1 |
| Specificity (%) | 95.1 |
| Contains an internal control line for the confirmation that the test has been performed correctly | Yes |
| Storage temperature | 2 degree C to 30 degree 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 Rules, 1945 | Yes |
KIT CONTENTS
| Main items in test kit for performing the test | Card |
| Sample Dropper Provided with each card | Yes |
| Sample Diluent/Assay Buffer Provided | Yes |
| Dessicant to absorb moisture so that the Card do not get spoiled | 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 |
| Clean, dry sterilized sample collection container present with the kit | Yes |
| Other accessories and spares provided if any for standard pack in the kit | NA |
PACKAGING
| Pack Size | 50 Tests Pack |
| The packing and labelling should be as per Drugs and Cosmetics Act, 1940 | 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 moisture proof pouches | Yes |
| Test Kit container for housing all the items in the kit | 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 (Proof of the same to be submitted to buyer on demand) | 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 Selling |
| Drug License Number | 242 |
| Drug License Date | 09-09-2017 |
| Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) | WHO GMP |
| GMP/ WHO GMP Certification Number | 1877/MFG/DC/VOL.-III/1977 |
| GMP/ WHO GMP Certification Date | 06-07-2018 |
| ISO 13485 Certified Manufacturer (Proof of the same to be submitted to buyer on demand if Certification is available) | Yes |
| Product Certifications (Proof of the same to be submitted to buyer on demand) | US-FDA |
| Four digit number of notified body If product is EU-CE certified | 5784 |
| 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 National Institute of Biological Sciences | ANY GOVT APPROVED LAB |
SHELF LIFE
| Shelf Life (in months) | 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 |
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