The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for
FDA 510(k) K983804 · Zeus Scientific, Inc.
510(k) numberK983804
Submission
- Device name
- The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- October 28, 1998
- Decision date
- December 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSE – Epstein-Barr Virus, Other
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code LSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | Biokit, S.A. | 08/07/2024SE |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | DiaSorin, Inc. | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | DiaSorin, Inc. | 01/04/2017SE |
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | Quest Intl., Inc. | 06/08/2009SE |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | Focus Diagnostics, Inc. | 07/28/2008SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K060204 | Liaison Ea IggLSE · Traditional | DiaSorin, Inc. | 10/18/2006SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | Quest Intl., Inc. | 01/16/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | Panbio Limited | 06/27/2003SE |
More from Panbio Limited
| 510(k) | Device | Decision |
|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | 08/21/2026SE |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | 05/08/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | 05/07/2025SE |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | 07/13/2023SE |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for cleared by the FDA?
The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for (K983804) received a 510(k) decision of Substantially Equivalent on December 8, 1998, 41 days after the submission was received.
What is the product code of K983804?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.