The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Staphylococcus Blood Culture Nucleic Acid Test (bc-s).
| Device ID | K112424 |
| 510k Number | K112424 |
| Device Name: | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Mark Del Vecchio |
| Correspondent | Mark Del Vecchio NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2011-12-16 |
| Summary: | summary |