FDA 510(k)

Borrelia B31 ViraChip IgG Test Kit

K-Number: K163504 · 2017-07-12

Decision Date2017-07-12

Product CodeLSR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Borrelia B31 ViraChip IgG Test Kit is a medical device manufactured by Viramed Biotech AG. It received FDA 510(k) clearance on 2017-07-12 under approval number K163504. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Borrelia B31 ViraChip IgG Test Kit?

Borrelia B31 ViraChip IgG Test Kit is a medical device that received FDA 510(k) clearance on 2017-07-12. It is manufactured by Viramed Biotech AG. The 510(k) number is K163504.

When was Borrelia B31 ViraChip IgG Test Kit approved by the FDA?

Borrelia B31 ViraChip IgG Test Kit received FDA 510(k) clearance on 2017-07-12, under approval number K163504.

What company makes Borrelia B31 ViraChip IgG Test Kit?

Borrelia B31 ViraChip IgG Test Kit is manufactured by Viramed Biotech AG.

What is the FDA product code for Borrelia B31 ViraChip IgG Test Kit?

The FDA product code for Borrelia B31 ViraChip IgG Test Kit is LSR.

Other Devices by Viramed Biotech AG

K163695Borrelia B31 ViraChip IgM Test Kit K220016Viramed Borrela All-In-One ViraChip Test Kit

Related Devices (Code: LSR)

K161513Anti-Borrelia burgdorferi US Westernblot (IgG)Euroimmun US K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)Euroimmun Us, Inc. K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation K163695Borrelia B31 ViraChip IgM Test KitViramed Biotech AG K163095Lyme B. burgdorferi (IgG) MarStripe TestTrinity Biotech

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.