510(k) K152353
- Device
- SeraQuest HSV Type 2 Specific IgG
- Applicant
- Quest International, Inc.
- 510(k) number
- K152353
- Product code
- MYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-13
- Date received
- 2015-08-20
- Regulation
- 866.3305
- Classification name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David J Kiefer
- Address
- 8127 NW 29th St. Mami FL US 33122 33122
FDA Registration Numbers#
- 3032705
- 1641328
- 9610126
- 9610746
- 2029372
- 2915274
- 3008344661
- 2182595
- 2242436
- 1318354
- 2023365
- 3005333358
- 2432235
Source Documents#
Other 510(k) Records For Product Code MYF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. | 2025-02-12 |
| K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022-10-12 |
| K181514 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | 2019-06-13 |
| K181334 | ADVIA Centaur Herpes-2 IgG | Biokit, S.A. | 2018-08-23 |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-05-20 |
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | DiaSorin, Inc. | 2008-11-10 |
| K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | Euroimmun Us, LLC | 2007-06-28 |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | 2004-07-13 |
| K993724 | HSV-2 ELISA IGG, MODEL EL0920G | Mrl Diagnostics | 2000-02-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary