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

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

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·January 22, 2025

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·April 13, 2022

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Enforcement
    Class II ·Ongoing·EMPATICA SRL·November 1, 2023

    SQ40S Blood Transfusion Filter

    FDA Enforcement
    Class II ·Ongoing·GVS TM, Inc·January 28, 2026

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    FDA Enforcement
    Class II ·Ongoing·GS Biomark LLC·December 7, 2022