510(k) K181333
- Device
- ADVIA Centaur Herpes-1 IgG
- Applicant
- Biokit, S.A.
- 510(k) number
- K181333
- Product code
- MXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-23
- Date received
- 2018-05-21
- Regulation
- 866.3305
- Classification name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joan Guixer
- Address
- Can Male S/N Lliça D'Amunt ES 08186 08186
FDA Registration Numbers#
- 3032705
- 1641328
- 9610126
- 9610746
- 2029372
- 2915274
- 2182595
- 2242436
- 2020726
- 1318354
- 2023365
- 3005333358
- 2432235
Source Documents#
Other 510(k) Records For Product Code MXJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Biokit, S.A. | 2023-09-20 |
| K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | 2022-10-12 |
| K162276 | SeraQuest Herpes Type 1 Specific IgG | Quest International, Inc. | 2016-10-01 |
| K143236 | Theranos Herpes Simplex Virus-1 IgG Assay | Theranos, Inc. | 2015-07-02 |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | Gold Standard Diagnostics | 2014-02-28 |
| K120625 | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV | Roche Diagnostics | 2012-07-25 |
| K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | Bio-Rad Laboratories | 2012-06-22 |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-04-26 |
| K090409 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2009-05-08 |
| K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | DiaSorin, Inc. | 2008-11-18 |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2008-05-30 |
| K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G | Focus Diagnostics, Inc. | 2007-10-05 |
| K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 | Focus Diagnostics, Inc. | 2007-09-24 |
| K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | Focus Diagnostics, Inc. | 2007-02-01 |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | 2004-07-13 |
Legacy Summary#
summary
FDA Review#
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