The following data is part of a De Novo classification by Nanosphere, Inc with the FDA for Verigene Gram Positive Blood Culture Nucleic Acid Test (bc-gp).
| DeNovo ID | DEN120014 |
| Device Name: | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) |
| Classification | Gram-positive Bacteria And Their Resistance Markers |
| Applicant | NANOSPHERE, INC 4088 Commercial Avenue Northbrook, IL 60062 |
| Contact | Mark Del Vecchio |
| Product Code | PAM |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K113450 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2012-06-15 |
| Decision Date | 2012-06-26 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857573006287 | DEN120014 | 000 |
| 00857573006218 | DEN120014 | 000 |
| 00857573006119 | DEN120014 | 000 |