Panels › Microbiology › Product code PII · Class 2
Candida Species Nucleic Acid Detection System
Regulation 866.3960
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PII
| Company | 510(k)s | Recalls |
|---|---|---|
| T2biosystems, Inc. | 3 | 0 |
| T2 Biosystems Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2016 | T2 Biosystems Inc T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base).
A qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida spec Terminated |
PII | None listed |
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