Plexus Herpeselect 1 and 2 Igg (with Plexus TM Software), Model MP0900G
FDA 510(k) K071511 · Focus Diagnostics, Inc.
510(k) numberK071511
Submission
- Device name
- Plexus Herpeselect 1 and 2 Igg (with Plexus TM Software), Model MP0900G
- Applicant
- Focus Diagnostics, Inc.
Cypress, CA, US - Received
- June 4, 2007
- Decision date
- October 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
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| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | Biokit, S.A. | 09/20/2023SE |
| K220923 | Elecsys HSV-1 IgG (08948844160)MXJ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | Biokit, S.A. | 08/23/2018SE |
| K162276 | SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional | Quest International, Inc. | 10/01/2016SE |
| K143236 | Theranos Herpes Simplex Virus-1 IgG AssayMXJ · Traditional | Theranos, Inc. | 07/02/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | Gold Standard Diagnostics | 02/28/2014SE |
| K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVMXJ · Traditional | Roche Diagnostics | 07/25/2012SE |
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg KitMXJ · Traditional | Bio-Rad Laboratories | 06/22/2012SE |
| K103363 | Zeus Elisa HSV Gc-I Igg Test SystemMXJ · Traditional | Zeus Scientific, Inc. | 04/26/2011SE |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemMXJ · Traditional | Bio-Rad Laboratories | 05/08/2009SE |
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| 510(k) | Device | Decision |
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| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackPGX · Traditional | 03/18/2015SE |
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| K141458 | Simplexa HSV 1&2 Direct/Positive Control PackPGH · Special | 07/01/2014SE |
| K120986 | Stratify JCV DxselectOYP · Traditional | 08/16/2012SE |
| K120413 | Simplexa Flu A/B & RSV Direct, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | 07/13/2012SE |
| K113433 | Simplexa C. Difficile Universal DirectOMN · Traditional | 04/04/2012SE |
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Questions and answers
When was Plexus Herpeselect 1 and 2 Igg (with Plexus TM Software), Model MP0900G cleared by the FDA?
Plexus Herpeselect 1 and 2 Igg (with Plexus TM Software), Model MP0900G (K071511) received a 510(k) decision of Substantially Equivalent on October 5, 2007, 123 days after the submission was received.
What is the product code of K071511?
The FDA product code is MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, a Class II (moderate risk) device regulated under 21 CFR 866.3305.