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MIY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3135
Medical specialty
Microbiology
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RecordFirmDate
PREMIER COCCIDIOIDES (K915493)Meridian Diagnostics, Inc.1992-07-10

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Every clearance here is in the API, with alerts when new ones post.