BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Ongoing × Clear all

    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

    FDA Enforcement
    Class III ·Ongoing·DRG International, Inc.·August 21, 2024

    RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578

    FDA Enforcement
    Class III ·Ongoing·Mechatronics USA·June 14, 2023

    RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577

    FDA Enforcement
    Class III ·Ongoing·Mechatronics USA·June 14, 2023