Food and Drug BlogWhich In Vitro Diagnostic Tests needs to be registered and which are exempted?

December 18, 2012

In Vitro Diagnostic Medical Device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information  concerning a physiological or pathological state, or — concerning a congenital abnormality, or — to determine the safety and compatibility with potential recipients, or — to monitor therapeutic measures.

Did you know that not all In Vitro Diagnostics Test Kits are for registration? There are some kits that need to be registered, but there are those which are exempted. However, exempted companies should still seek for a certificate from the Center for Device Regulation, Radiation Health and Research. There is a big difference in the process of application and approval between the registerable and non-registerable In Vitro Diagnostic Kits. Registerable kits are required to submit technical documentation of the product and are required for further testing of the Government before it can be approved.

In Vitro Diagnostic Test Kits that needs to be registered are the following:

  1. HIV Test Kits
  2. Hepatitis B and C Test Kits
  3. Drug Test Kits
  4. Pregnancy Test Kits
  5. Blood Test Kits
  6. Leptospirosis Test Kits

Triple i Consulting Inc. can assist you in the preparation of documents for submission and facilitation of your registration. Please contact us at and our Account Manager will assist you with any questions you may have regarding FDA Consulting.

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