VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
FDA 510(k) clearance K123197 · decided 2012-12-05
Clearance details
- K-number
- K123197
- Device name
- VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
- Applicant
- Nanosphere, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-11
- Decision date
- 2012-12-05
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- 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 Clostridium difficile Nucleic Acid Test, REF 30-002-022 recall (Z-2024-2023) | Luminex Corporation | 2023-06-28 |
| The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed i recall (Z-2682-2014) | Nanosphere, Inc. | 2014-09-23 |
| Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a V recall (Z-2168-2014) | Nanosphere, Inc. | 2014-08-08 |