8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
FDA Enforcement
Class II
·Ongoing·DiaSorin Molecular LLC·March 15, 2023
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
FDA Enforcement
Class II
·Ongoing·DiaSorin Molecular LLC·March 15, 2023
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
FDA Enforcement
Class II
·Terminated·DiaSorin Molecular LLC·July 22, 2020
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.
FDA Enforcement
Class II
·Terminated·DiaSorin Molecular LLC·July 22, 2020
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).
FDA Enforcement
Class II
·Terminated·DiaSorin Molecular LLC·July 22, 2020
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
FDA Enforcement
Class II
·Ongoing·DiaSorin Molecular LLC·October 27, 2021
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
FDA Enforcement
Class II
·Ongoing·DiaSorin Molecular LLC·January 12, 2022
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
FDA Enforcement
Class II
·Ongoing·DiaSorin Molecular LLC·July 26, 2023