ADVIA Centaur EBV-EBNA IgG
FDA 510(k) K233605 · Biokit, S.A.
510(k) numberK233605
Submission
- Device name
- ADVIA Centaur EBV-EBNA IgG
- Applicant
- Biokit, S.A.
Lliçà DAmunt, Barcelona, ES - Received
- November 9, 2023
- Decision date
- August 7, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LLM – Test, Antigen, Nuclear, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code LLM
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|---|---|---|---|
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysLLM · Traditional | DiaSorin, Inc. | 04/29/2005SE |
| K984133 | The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked…LLM · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
| K973941 | Immunowell Ebna Igg TestLLM · Traditional | Genbio | 08/10/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | Clark Laboratories, Inc. | 05/01/1998SE |
| K951549 | Ebna Igg Eia Test SystemLLM · Traditional | Immunoprobe, Inc. | 04/29/1996SE |
| K951822 | Ebna Enzyme Immunoassay KitLLM · Traditional | Granbio, Inc. | 02/15/1996SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | Gull Laboratories, Inc. | 09/19/1995SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | Mrl Diagnostics | 07/21/1995SE |
| K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitLLM · Traditional | Incstar Corp. | 06/09/1995SE |
| K932742 | Ebna Igg Elisa Test SystemLLM · Traditional | Zeus Scientific, Inc. | 05/05/1995SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF · Traditional | 02/12/2025SE |
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | 08/07/2024SE |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | 09/20/2023SE |
| K214068 | Quantia IgEDGC · Special | 02/21/2023SE |
| K181334 | ADVIA Centaur Herpes-2 IgGMYF · Traditional | 08/23/2018SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | 08/23/2018SE |
| K152185 | Architect SHBGCDZ · Traditional | 02/11/2016SE |
| K132400 | Lp(A) Calibrators, and Lp(A) ControlsJIT · Abbreviated | 12/19/2013SE |
| K123947 | Architect IvancomycinLEH · Traditional | 08/29/2013SE |
| K110619 | Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsMRG · Traditional | 11/23/2011SE |
Questions and answers
When was ADVIA Centaur EBV-EBNA IgG cleared by the FDA?
ADVIA Centaur EBV-EBNA IgG (K233605) received a 510(k) decision of Substantially Equivalent on August 7, 2024, 272 days after the submission was received.
What is the product code of K233605?
The FDA product code is LLM – Test, Antigen, Nuclear, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.