LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
FDA 510(k) clearance K081687 · decided 2008-11-10
Clearance details
- K-number
- K081687
- Device name
- LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-17
- Decision date
- 2008-11-10
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- MYF
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575) | Biokit, S.A. | 2025-02-12 |
| Elecsys HSV-2 IgG (08948887160) (K220924) | Roche Diagnostics | 2022-10-12 |
| SeraQuest HSV Type 2 Specific IgG (K181514) | Quest International, Inc. | 2019-06-13 |
| ADVIA Centaur Herpes-2 IgG (K181334) | Biokit, S.A. | 2018-08-23 |
| SeraQuest HSV Type 2 Specific IgG (K152353) | Quest International, Inc. | 2016-05-13 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (K061239) | Euroimmun Us, LLC | 2007-06-28 |
| CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (K033106) | Trinity Biotech USA | 2004-07-13 |
| HSV-2 ELISA IGG, MODEL EL0920G (K993724) | Mrl Diagnostics | 2000-02-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 recall (Z-0815-2024) | Diasorin Inc. | 2024-01-25 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |