Viramed Borrela All-In-One ViraChip Test Kit
FDA 510(k) K220016 · Viramed Biotech AG
510(k) numberK220016
Submission
- Device name
- Viramed Borrela All-In-One ViraChip Test Kit
- Applicant
- Viramed Biotech AG
Planegg, DE - Received
- January 5, 2022
- Decision date
- August 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
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| K242872 | iDart Lyme IgM ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 06/12/2025SE |
| K233367 | iDart Lyme IgG ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 08/12/2024SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | Zeus Scientific | 07/13/2023SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | DiaSorin, Inc. | 02/18/2021SE |
More from DiaSorin, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163695 | Borrelia B31 ViraChip IgM Test KitLSR · Traditional | 08/22/2017SE |
| K163504 | Borrelia B31 ViraChip IgG Test KitLSR · Traditional | 07/12/2017SE |
| K092693 | Viramed Biotech AG Borrelia B31 Igg Virastripe, Model V-BbsgusLSR · Traditional | 11/25/2009SE |
| K082329 | Viramed Biotech AG Borrelia B31 Igm VirastripeLSR · Traditional | 08/05/2009SE |
| K051169 | Biramed Biotech Borrelia B31 Igm VirablotLSR · Traditional | 08/11/2005SE |
| K051071 | Viramed Biotech Borrelia B31 Igg VirablotLSR · Traditional | 08/11/2005SE |
Questions and answers
When was Viramed Borrela All-In-One ViraChip Test Kit cleared by the FDA?
Viramed Borrela All-In-One ViraChip Test Kit (K220016) received a 510(k) decision of Substantially Equivalent on August 19, 2022, 226 days after the submission was received.
What is the product code of K220016?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.