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Priority List

KMLTTB has selected Class 4 and some Class 3 IVD’s as the initial priority and all products in class 4 shall undergo evaluation. In addition, the Board has taken special focus on the following diagnostic tests due to their public health importance.

The priority tests and their specific costs include:

1)     All HIV/ AIDS Diagnostics                                                    USD 50,000

(Inclusive of Rapid kits and point of Care)

2)     Hepatitis Band C test Kits                                                    USD50,000

3)     West Nile virus                                                                    USD 30,000

4)     Dengue Virus                                                                      USD 30,000

5)     Malaria Rapid Diagnostic Testing Kit                                  USD 20,000

6)     Typhoid Rapid Test (Widal Test)                                        USD20,000

7)     Brucellosis Rapid Testing kit                                               USD20,000

8)     Blood Glucose monitors                                                     USD 10,000

(Inclusive of home use and professional use Tests)

9)     Pregnancy Test kits                                                        USD 10,000

10)All other Point of Care testing devices                               USD 50,000

The fees shall be inclusive of the following:

  1. Administrative Costs
  2. Laboratory evaluation Costs
  3. Approval Committee costs
  4. Manufacturer’s site visit
  5. Laboratory Re-evaluation costs; applicable once only.

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