Atlas FDA

MXB

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Test, Vaginal, Bacterial Sialidase
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
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RecordFirmDate
MODIFICATION TO BVBLUE (K050755)Gryphus Diagnostics, LLC2005-04-06
BVBLUE (K993732)Gryphus Diagnostics, LLC2000-05-15

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