VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
FDA 510(k) clearance K132843 · decided 2014-01-08
Clearance details
- K-number
- K132843
- Device name
- VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
- Applicant
- Nanosphere, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-10
- Decision date
- 2014-01-08
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- PEN
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use wi recall (Z-1903-2025) | Luminex Corporation | 2025-06-03 |
| Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are recall (Z-2736-2014) | Nanosphere, Inc. | 2014-09-30 |
| The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sa recall (Z-2681-2014) | Nanosphere, Inc. | 2014-09-23 |
| Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Ca recall (Z-2236-2014) | Nanosphere, Inc. | 2014-08-14 |
| Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample recall (Z-2170-2014) | Nanosphere, Inc. | 2014-08-08 |