illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
FDA 510(k) clearance K151046 · decided 2015-07-17
Clearance details
- K-number
- K151046
- Device name
- illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-20
- Decision date
- 2015-07-17
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PGI
- Device class
- 2
- Regulation number
- 866.3309
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, 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 |
|---|---|---|
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (K232286) | Quidel Corporation | 2023-12-20 |
| Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (K192376) | Diasorin Molecular, LLC | 2019-11-26 |
| HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (K180559) | Elitechgroup | 2018-10-29 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K173798) | Diasorin Molecular, LLC | 2018-03-14 |
| Solana HSV 1+2/VZV Assay (K162451) | Quidel Corporation | 2016-11-28 |
| ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) (K151906) | Luminex Corporation | 2015-10-06 |
| QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (DEN140004) | Diagnostic Hybrids, Inc. | 2014-05-13 |
Recalls involving this device
No recalls on record reference this clearance.