Bioplex 2200 HSV-1 and HSV-2 Igg Kit
FDA 510(k) K120959 · Bio-Rad Laboratories
510(k) numberK120959
Submission
- Device name
- Bioplex 2200 HSV-1 and HSV-2 Igg Kit
- Applicant
- Bio-Rad Laboratories
Benicia, CA, US - Received
- March 30, 2012
- Decision date
- June 22, 2012
- 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 |
| 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 |
| K081685 | Liaison HSV-1 Type Specific Igg Assay, Control HSV-1 IggMXJ · Traditional | DiaSorin, Inc. | 11/18/2008SE |
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Questions and answers
When was Bioplex 2200 HSV-1 and HSV-2 Igg Kit cleared by the FDA?
Bioplex 2200 HSV-1 and HSV-2 Igg Kit (K120959) received a 510(k) decision of Substantially Equivalent on June 22, 2012, 84 days after the submission was received.
What is the product code of K120959?
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.