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510(k) K163695

Borrelia B31 ViraChip IgM Test Kit by Viramed Biotech AG — Product Code LSR

K163695 is an FDA 510(k) premarket notification submitted by Viramed Biotech AG for the device "Borrelia B31 ViraChip IgM Test Kit". The FDA issued a decision of Substantially Equivalent on August 22, 2017. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Viramed Biotech AG has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2017
Date Received
December 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Viramed Biotech AG

  • K220016 — Viramed Borrela All-In-One ViraChip Test Kit (August 19, 2022)
  • K163504 — Borrelia B31 ViraChip IgG Test Kit (July 12, 2017)
  • K092693 — VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS (November 25, 2009)
  • K082329 — VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE (August 5, 2009)
  • K051071 — VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT (August 11, 2005)
  • K051169 — BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT (August 11, 2005)

Other clearances for product code LSR

  • K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA (July 10, 2026)
  • K252627 — Lyme-ID IgG Test; Bio-ID800 (November 14, 2025)
  • K242872 — iDart Lyme IgM ImmunoBlot Kit (June 12, 2025)
  • K233367 — iDart Lyme IgG ImmunoBlot Kit (August 12, 2024)
  • K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl (July 13, 2023)
  • K220016 — Viramed Borrela All-In-One ViraChip Test Kit (August 19, 2022)
  • K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (March 22, 2021)
  • K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (March 22, 2021)

FDA data resources