Point of Care Diagnostic Test Kit – Typhoid Rapid Test Kit

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Description

GENERAL FEATURES

Product DescriptionTyphoid Rapid Test Kit
Clinical PurposeTo detect antibodies to Salmonella typhi in human serum or plasma
DetectsIgM Antibodies to salmonella typhi,IgG Antibodies to salmonella typhi
Type of TestQualitative
Testing PrincipleImmuno-chromatographic Principle
Specimen Required for testingPlasma
Result Time (min)15-20
Ability to Evaluate Negative or Positive test resultYes
Sensitivity (%)94.1
Specificity (%)95.1
Contains an internal control line for the confirmation that the test has been performed correctlyYes
Storage temperature2 degree C to 30 degree 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 Rules, 1945Yes

KIT CONTENTS

Main items in test kit for performing the testCard
Sample Dropper Provided with each cardYes
Sample Diluent/Assay Buffer ProvidedYes
Dessicant to absorb moisture so that the Card do not get spoiledYes
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
Clean, dry sterilized sample collection container present with the kitYes
Other accessories and spares provided if any for standard pack in the kitNA

PACKAGING

Pack Size50 Tests Pack
The packing and labelling should be as per Drugs and Cosmetics Act, 1940Yes
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 moisture proof pouchesYes
Test Kit container for housing all the items in the kitYes

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 (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 Number242
Drug License Date09-09-2017
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand)WHO GMP
GMP/ WHO GMP Certification Number1877/MFG/DC/VOL.-III/1977
GMP/ WHO GMP Certification Date06-07-2018
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 certified5784
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 National Institute of Biological SciencesANY 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 consigneeYes

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