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Medical Device or IVD Tubes

Updated: Jan 25

A worrying number of practitioners are still using IVD tubes for autologous therapy.


IVD tubes do not require any clinical evaluation process and they are not tested in the frame of biocompatibility. For this reason, IVD tubes are prohibited from clinical applications. i-PRF Smart Cell tubes are CE marked, Class IIb according to European Commission’s MEDDEV 93/42/EEC, Classification Document Annex IX with the Rule 3 that requires clinical evaluation and biocompatibility tests that lead to the permission of clinical applications.



Injecting

i-PRF Smart Cell tubes are not blood storage tube or IVD tubes. They are CE Class IIb Medical Devices licensed for autologous treatment.


CE Class IIb Medical Device

i-PRF Smart Cell tubes are Class IIb medical device Some IVD tubes are marketed for PRP treatments. IVD tubes are intended for in vitro diagnostics outside the human body. The section of the catalogues of these tubes express that do not inject to humans


Kits

“More than a tube.”

i-PRF Smart Cell kits are created in clean rooms, with medical grade components that have been tested for their safety, compatibility with blood, non-toxicity, no risk of alteration of the biological product, no risk of allergic reaction or irritation. In addition, to get certification, the performance of i-PRF medical devices have been demonstrated, not only for blood component separation but also at the clinical level, i-PRF Kits include the necessary equipments to be used for i-PRF treatments.


Anti-Coagulant


Sodium citrate, EDTA, and heparin are commonly used anticoagulants. Sodium citrate is the preferred anticoagulant for PRP, this prevents coagulation by forming a complex with calcium ions. Citrate is combined with preservative solutions (eg, citrate plus phosphate, dextrose, and adenine) Sodium citrate remains within the plasma, thus will be injected into the skin.

Heparin can often result in mild but irreversible platelet aggregation. Although serum tubes claim to be plain, they actually contain a clot activator


Gel Separation


The majority of PRP tubes contain a gel separator which contain silicone. Because of the gel separator, PRP tubes must be spun hard. Dr. Anil Rajani who is a Board-Certified Medical Doctor based in America highlights the risk of microdoses of the gel being re-injected into the skin.

There is no risk of this with i-PRF Smart Cell tubes.


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