VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
FDA 510(k) clearance K122514 · decided 2012-09-19
Clearance details
- K-number
- K122514
- Device name
- VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
- Applicant
- Nanosphere, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-17
- Decision date
- 2012-09-19
- Days to decision
- 33 days
- Clearance type
- Traditional
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test recall (Z-2533-2024) | Luminex Corporation | 2024-08-08 |
| Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic recall (Z-0500-2024) | Luminex Corporation | 2023-12-06 |
| Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blo recall (Z-0822-2019) | Luminex Corporation | 2019-02-11 |
| VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Pr recall (Z-0445-2019) | Luminex Corporation | 2018-11-10 |
| Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are recall (Z-2735-2014) | Nanosphere, Inc. | 2014-09-30 |
| The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sam recall (Z-2683-2014) | Nanosphere, Inc. | 2014-09-23 |