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MJM

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Dna Probe, Gardnerella Vaginalis
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Medical specialty
Microbiology
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RecordFirmDate
INDICARD TEST (K964015)Litmus Concepts, Inc.1997-06-19
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (K923133)Microprobe Corp.1992-09-25

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