Product Code: LSR


Products Classified as LSR

3460Reagent, Borrelia Serological ReagentTreponema Pallidum Treponemal Test Reagents.

Total Product Life Cycle (TPLC) Devices

3460Reagent, Borrelia Serological ReagentTreponema Pallidum Treponemal Test Reagents.

FDA Consensus Standards

Reagent, Borrelia Serological Reagent [25188]21 CFR §866.3830 🔎

Pre-market Notifications for LSR

K220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG
K203289Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC IgG/IgM ELISA Test KitGold Standard Diagnostics
K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusDiaSorin Inc.
K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusDiaSorin Inc.
K200025Gold Standard Diagnostics Borrelia Burgdorferi IgG ELISA Test KitGold Standard Diagnostics
K200023Gold Standard Diagnostics Borrelia Burgdorferi IgM ELISA Test KitGold Standard Diagnostics
K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetDiaSorin Inc.
K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia Burgdorferi IgG Test SystemZEUS Scientific Inc.
K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia Burgdorferi IgM Test SystemZEUS Scientific Inc.
K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia Burgdorferi IgG/IgM Test SystemZEUS Scientific, Inc.
K183446BioPlex 2200 Lyme TotalBio-Rad Laboratories
K180264Gold Standard Diagnostics Borrelia Burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics
K173691Sofia Lyme FIA, Sofia 2 Analyzer, Sofia 2 Installation PackQuidel Corporation
K173496Sofia 2 Lyme FIA, Sofia Lyme Control SetQuidel Corporation
K172722Anti-Borrelia Burgdorferi US EUROLINE-WB (IgM)EUROIMMUN US, Inc.

Global Unique Device Identification Database

00613745050256Reagent, Borrelia Serological Reagent
00613745039053Reagent, Borrelia Serological Reagent
00613745031101Reagent, Borrelia Serological Reagent
00816784020383Reagent, Borrelia Serological Reagent
00816784020376Reagent, Borrelia Serological Reagent
00863782000305Reagent, Borrelia Serological Reagent
00847865011495REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011488REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011471REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011464REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011457REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011280REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011273REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011266REAGENT, BORRELIA SEROLOGICAL REAGENT
00847865011259REAGENT, BORRELIA SEROLOGICAL REAGENT

Maude Adverse Events

VIDAS? LYME IGM II 60 TESTSBIOMERIEUX SA2020-01-31
VIDAS? LYME IGG II 60 TESTSBIOMERIEUX SA2020-01-30
VIDAS? LYME IGG II 60 TESTSBIOMERIEUX SA2020-01-30
VIDAS? LYME IGMBIOMERIEUX SA2019-12-06
VIDAS? LYME IGGBIOMERIEUX SA2019-10-10
VIDAS? LYME IGGBIOMERIEUX SA2019-09-17
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? TOXO IGMBIOMERIEUX SA2019-08-27
VIDAS? LYME IGGBIOMERIEUX SA2019-08-23
VIDAS? LYME IGGBIOMERIEUX SA2019-08-21
LYME TESTINGUNK2019-06-05
LYME TESTINGUNK2019-06-05
LYME TESTINGUNK2019-06-05
LYME TESTINGUNK2019-06-05
VIDAS? LYME IGGBIOMERIEUX SA2019-01-03
VIDAS? LYME IGGBIOMERIEUX SA2018-12-19
VIDAS? LYME IGGBIOMERIEUX SA2018-11-13
VIDAS? LYME IGGBIOMERIEUX SA2018-10-12
VIDAS? LYME IGGBIOMERIEUX SA2018-10-09
VIDAS? LYME IGMBIOMERIEUX SA2017-12-05
VIDAS? LYME IGGBIOMERIEUX SA2017-12-01
VIDAS? LYME IGMBIOMERIEUX, SA2017-12-01
VIDAS? LYME IGGBIOMERIEUX, SA2017-12-01
VIDAS? LYME IGMBIOMERIEUX SA2017-12-01
WESTERN BLOTUNK2017-10-20
WESTERN BLOTUNK2017-10-20
ELISAUNK2017-10-20
VIDAS? LYME IGMBIOMERIEUX SA2017-06-20
WESTERN BLOT - LYME TWO TIER TESTING SYSTEMUNK2017-01-18
ELISAUNK2017-01-18
VIDAS? LYME IGGBIOMERIEUX SA2016-12-20
VIDAS? LYME IGGBIOMERIEUX, S.A.2016-12-08
VIDAS? LYME IGM IIBIOMERIEUX SA2016-09-28
VIDAS? LYME IGGBIOMERIEUX SA2016-08-30
VIDAS? LYME IGGBIOMERIEUX SA2016-08-18
VIDAS? LYME IGGBIOMERIEUX SA2016-06-20
WESTERN BLOT BLOOD TESTUNK2016-05-17
VIDAS? LYME IGGBIOMERIEUX SA2016-03-15
VIDAS? LYME IGM IIBIOMERIEUX SA2016-03-03
VIDAS? LYME IGGBIOMERIEUX SA2016-02-02
VIDAS ? PC COMPUTER HP RP5700BIOMERIEUX SA2015-11-30
ELISA TEST SYSTEM2015-11-30
VIDAS? LYME IGGBIOMERIEUX SA2015-10-21
VIDAS? LYME IGGBIOMERIEUX SA2015-10-16
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