Biological Indicator of the self-contained type, with a maximum response time of 24  hours, for biological control of formaldehyde sterilization processes. The strip containing spores is stored in a plastic ampoule that also contains a glass ampoule containing a nutrient broth suitable for the cultivation of microorganisms. The plastic ampoule is closed by a perforated cap and protected by a hydrophobic filter paper. Each ampoule has an external label that informs the batch and the date of manufacture of the product, containing fields for identification of the ampoule and an external chemical indicator that differentiates the processed ampoules from the unprocessed ones.

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Product  free  registration in the MS According to RDC 185/2001 and sanitary classification as – Products not considered health products.