VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
FDA 510(k) clearance DEN120014 · decided 2012-06-26
Clearance details
- K-number
- DEN120014
- Device name
- VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
- Applicant
- Nanosphere, Inc.
- Decision
- Unknown
- Date received
- 2012-06-15
- Decision date
- 2012-06-26
- Days to decision
- 11 days
- Clearance type
- Post-NSE
- Product code
- PAM
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 |
| LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) | Luminex Corporation | 2025-06-06 |
| ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) | Genmark Diagnostics, Incorporated | 2018-12-20 |
| iC-GPC Assay TM for use on the iC-SystemTM (K163390) | Icubate, Inc. | 2017-08-08 |
| Great Basin Staph ID/R Blood Culture Panel (K152470) | Great Basin Scientific, Inc. | 2016-03-25 |
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |
Recalls involving this device
No recalls on record reference this clearance.