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QCH

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Assayed Quality Control Material For Clinical Microbiology Assays
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3920
Medical specialty
Microbiology
FDA definition
Serologic controls for microbiology assays
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RecordFirmDate
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) (K242492)Techno-Path Manufacturing , Ltd.2025-12-30

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