Legionella, Spp., Elisa

Device Code: 3493

Product Code(s): MJH

Device Classification Information

Device Type ID3493
Device NameLegionella, Spp., Elisa
Regulation DescriptionHaemophilus Spp. Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMJH
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3493
DeviceLegionella, Spp., Elisa
Product CodeMJH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHaemophilus Spp. Serological Reagents.
CFR Regulation Number866.3300 [🔎]
Premarket Reviews
ManufacturerDecision
MERIDIAN BIOSCIENCE, INC.
 
SUBSTANTIALLY EQUIVALENT
1
MERIDIAN CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:31:07

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