Captia HSV 1 Igg Type Specific Elisa Kit
FDA 510(k) K033105 · Trinity Biotech USA
510(k) numberK033105
Submission
- Device name
- Captia HSV 1 Igg Type Specific Elisa Kit
- Applicant
- Trinity Biotech USA
Jamestown, NY, US - Received
- September 30, 2003
- Decision date
- July 13, 2004
- 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
Other 510(k)s with product code MXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Bio-Rad Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K140455 | Captia Measles IgmPCL · Traditional | 05/22/2014SE |
| K033106 | Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional | 07/13/2004SE |
| K033083 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | 11/26/2003SE |
| K033070 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033067 | Pylori IggLYR · Traditional | 11/26/2003SE |
| K033064 | Mycoplasma IggLON · Traditional | 11/26/2003SE |
| K033051 | Legionella Pneumophila Igg/IgmMJH · Traditional | 11/26/2003SE |
| K993839 | Ena Profile Elisa Test SystemLLL · Traditional | 01/12/2000SE |
| K992665 | Macra Lp(A) Enzyme Immunoassay KitDFC · Traditional | 11/26/1999SE |
Questions and answers
When was Captia HSV 1 Igg Type Specific Elisa Kit cleared by the FDA?
Captia HSV 1 Igg Type Specific Elisa Kit (K033105) received a 510(k) decision of Substantially Equivalent on July 13, 2004, 287 days after the submission was received.
What is the product code of K033105?
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.