Point of Care Diagnostic Test Kit – Rotavirus Antigen Rapid Test Kit

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Description

GENERAL FEATURES

Product DescriptionRotavirus Antigen Rapid Test Kit
Clinical PurposeTo detect Rotavirus antigen in Stool Samples for diagnosis of Gastroenteritis
Type of TestQualitative
Testing PrincipleImmuno-chromatographic Principle
Specimen Required for testingStool
Result Time (min)10-20
Ability to Evaluate Negative or Positive test resultYes
Sensitivity (%)97
Specificity (%)97
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

KIT CONTENTS

Main items in test kit for performing the testCard
Clean, dry sterilized sample collection tube filled with sample diluent present with each kitYes
Sample dropper providedYes
Swab/spoon to collect specimen ProvidedNo
Dessicant to absorb moisture so that the Card/Strip do not get spoiledYes
Reactive and non reactive controls provided with each kit in adequate volume (minimum 10% of pack size)No
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
Other accessories and spares provided if any for standard pack in the kit1. Mytest Rotavirus Ag Device individually foil pouched with a desiccant. 2. Extraction Buffer bottle. 3. Package insert (instruction for use).

PACKAGING

Pack Size10 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 Manufacturing
Drug License NumberN(1091)15/W
Drug License Date05.11.2015
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand)GMP
GMP/WHO GMP Certification NumberW(0052)/14/MB/MFG/DC/1907
GMP/WHO GMP Certification Date28-06-2017
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)EU-CE
Four digit number of notified body If product is EU-CE certified1804
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 bodyAny other govt approved lab
Name of the Performance Evaluation Report issuing body if other than National Institute of Biological SciencesMFG QC Lab Reports , CP LABS

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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