Panels › Microbiology › Product code SBT · Class 2
Device To Detect Microbial Colonization Directly From Clinical Specimens.
Regulation 866.3967
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SBT
| Company | 510(k)s | Recalls |
|---|---|---|
| Diasorin Molecular, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2024 | DEN230092 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, Diasorin Molecular, LLC | SBT |
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