Reagent, Borrelia Serological Reagent

LSR 2025-11-14

Lyme-ID IgG Test; Bio-ID800

Applicant Inanovate, Inc.

K number K252627

LSR 2025-06-12

iDart Lyme IgM ImmunoBlot Kit

Applicant Id-Fish Technology, Inc.

K number K242872

LSR 2024-08-12

iDart Lyme IgG ImmunoBlot Kit

Applicant Id-Fish Technology, Inc.

K number K233367

LSR 2023-07-13

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

Applicant Zeus Scientific

K number K230863

LSR 2022-08-19

Viramed Borrela All-In-One ViraChip Test Kit

Applicant Viramed Biotech AG

K number K220016

LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

K number K203296

LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

K number K203295

LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

K number K203292

LSR 2021-03-22

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

K number K203289

LSR 2021-02-18

LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus

Applicant DiaSorin, Inc.

K number K202574

LSR 2021-02-18

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus

Applicant DiaSorin, Inc.

K number K202573

LSR 2020-04-06

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

K number K200025

LSR 2020-04-06

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

K number K200023

LSR 2020-01-29

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

Applicant DiaSorin, Inc.

K number K193051

LSR 2019-07-29

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System

Applicant Zeus Scientific, Inc.

K number K191398

LSR 2019-07-29

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System

Applicant Zeus Scientific, Inc.

K number K191240

LSR 2019-07-29

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System

Applicant Zeus Scientific, Inc.

K number K190907

LSR 2019-03-12

BioPlex 2200 Lyme Total

Applicant Bio-Rad Laboratories

K number K183446

LSR 2018-08-30

Sofia 2 Lyme FIA, Sofia Lyme Control Set

Applicant Quidel Corporation

K number K173496

LSR 2018-05-02

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

K number K180264

LSR 2018-02-28

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

Applicant Quidel Corporation

K number K173691

LSR 2017-12-10

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Applicant Euroimmun Us, Inc.

K number K172722

LSR 2017-10-23

Lyme B. burgdorferi (IgM) MarStripe Test

Applicant Trinity Biotech

K number K172254

LSR 2017-10-20

Sofia Lyme FIA, Sofia Lyme Control Set

Applicant Quidel Corporation

K number K163713

LSR 2017-08-22

Borrelia B31 ViraChip IgM Test Kit

Applicant Viramed Biotech AG

K number K163695

LSR 2017-07-12

Borrelia B31 ViraChip IgG Test Kit

Applicant Viramed Biotech AG

K number K163504

LSR 2017-02-01

Lyme B. burgdorferi (IgG) MarStripe Test

Applicant Trinity Biotech

K number K163095

LSR 2016-08-25

Anti-Borrelia burgdorferi US Westernblot (IgG)

Applicant Euroimmun US

K number K161513

LSR 2013-06-04

VIDAS LYME IGM

Applicant Biomerieux S.A.

K number K122979

LSR 2013-03-05

VIDAS LYME IGG

Applicant Biomerieux S.A.

K number K122986

LSR 2012-07-26

ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K113397

LSR 2012-06-01

BORRELIA BURGDORFERI IGM BLOT TEST

K number K113846

LSR 2012-04-11

BORRELIA BURGDORFERI IGG BLOT TEST

K number K113847

LSR 2010-07-06

ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K100728

LSR 2009-11-25

VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS

Applicant Viramed Biotech AG

K number K092693

LSR 2009-08-05

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE

Applicant Viramed Biotech AG

K number K082329

LSR 2008-06-26

PLATELIA LYME IGM

Applicant Bio-Rad

K number K081362

LSR 2008-05-08

PLATELIA LYME IGG ASSAY

Applicant Bio-Rad

K number K080012

LSR 2007-04-12

LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871

Applicant DiaSorin, Inc.

K number K062473

LSR 2005-08-11

BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT

Applicant Viramed Biotech AG

K number K051169

LSR 2005-08-11

VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT

Applicant Viramed Biotech AG

K number K051071

LSR 2003-11-26

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

Applicant Trinity Biotech USA

K number K033083

LSR 2003-11-26

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

Applicant Trinity Biotech USA

K number K033070

LSR 2003-11-24

BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG

Applicant Boston Biomedica, Inc.

K number K032713

LSR 2001-05-10

IMMUNETICS C6 LYME ELISA KIT

Applicant Immunetics, Inc.

K number K003754

LSR 2000-01-27

QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT

Applicant Inova Diagnostics, Inc.

K number K994004

LSR 1999-09-21

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

Applicant Immunetics, Inc.

K number K991063

LSR 1999-09-21

QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

Applicant Immunetics, Inc.

K number K991062

LSR 1999-09-03

BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K991185

LSR 1999-09-03

BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K991180

LSR 1999-04-15

QUANTA LITE LYME IGM ELISA

Applicant Inova Diagnostics, Inc.

K number K984234

LSR 1999-04-15

QUANTA LITE LYME IGG ELISA

Applicant Inova Diagnostics, Inc.

K number K984222

LSR 1999-03-23

APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K984138

LSR 1999-03-05

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT

Applicant Boston Biomedica, Inc.

K number K980351

LSR 1999-02-12

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

Applicant Chembio Diagnostic Systems, Inc.

K number K981913

LSR 1998-12-16

IS BORRELIA BURGDORFERI IGM TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K983606

LSR 1998-12-16

IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K983605

LSR 1998-06-01

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)

Applicant Mrl Diagnostics

K number K971007

LSR 1998-06-01

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)

Applicant Mrl Diagnostics

K number K971006

LSR 1998-04-09

HUMAN LYME IGM WESTERN BLOT KIT

Applicant Cambridge Diagnostics Ireland, Ltd.

K number K970768

LSR 1998-04-09

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)

Applicant Cambridge Diagnostics Ireland, Ltd.

K number K970761

LSR 1998-02-17

CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)

Applicant Cambridge Biotech Corp.

K number K971170

LSR 1998-02-17

CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)

Applicant Cambridge Biotech Corp.

K number K971169

LSR 1998-02-05

ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL

Applicant Boston Biomedica, Inc.

K number K974810

LSR 1998-02-05

ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL

Applicant Boston Biomedica, Inc.

K number K974809

LSR 1997-03-26

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

Applicant Wampole Laboratories

K number K965131

LSR 1997-03-26

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

Applicant Wampole Laboratories

K number K965129

LSR 1996-06-07

MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K951709

LSR 1996-06-05

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K950829

LSR 1996-05-03

MMUNO DOT BORRELIA DOT BLOT M TEST

Applicant Genbio

K number K953683

LSR 1996-05-03

IMMUNO DOT BORRELIA DOT BLOT G TEST

Applicant Genbio

K number K953682

LSR 1995-06-13

VIDAS LYME SCREEN II

Applicant Biomerieux Vitek, Inc.

K number K943812

LSR 1992-09-02

BARTELS LYME DISEASE IGM EIA

Applicant Baxter Diagnostics, Inc.

K number K922578

LSR 1992-04-08

IMMUNODOT BORRELIA (LYME) TEST

K number K911627

LSR 1991-12-30

IMMUNOWELL LYME (P39 RECOMBINANT) TEST

K number K911599

LSR 1991-12-20

IMMUNOWELL BORRELIA (LYME)TEST

K number K911590

LSR 1991-11-05

LYME-CHECK(TM) TEST KIT

Applicant Diagnostic Technology, Inc.

K number K896378

LSR 1991-10-21

LYME STAT M TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K904652

LSR 1991-10-16

FIAX LYME M TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K904893

LSR 1991-08-30

LYME-SPOT IF KIT

Applicant Vitek Systems, Inc.

K number K910230

LSR 1991-06-28

LYME DISEASE IGM ELISA

Applicant Hillcrest Biologicals

K number K900206

LSR 1991-06-24

FASTTECH SYSTEM 1

Applicant 3M Diagnostic Systems, Inc.

K number K911496

LSR 1991-06-21

LYME IGM ELISA TEST

Applicant Gull Laboratories, Inc.

K number K903013

LSR 1991-06-10

LYME IGM MICROASSAY

Applicant Diamedix Corp.

K number K911330

LSR 1991-06-10

LYME DISEASE MICROASSAY

Applicant Diamedix Corp.

K number K910899

LSR 1991-05-10

BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST

Applicant Medical Diagnostic Technologies, Inc.

K number K911145

LSR 1990-12-14

3M IGG FASTLYME(TM) TEST

Applicant 3M Company

K number K895713

LSR 1990-05-02

LYME IGM MICROASSAY

Applicant Diamedix Corp.

K number K900572

LSR 1990-05-02

LYME IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K900196

LSR 1990-04-05

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE

Applicant Bion Ent., Ltd.

K number K901054

LSR 1989-12-13

LYME IGG ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K895292

LSR 1989-10-30

IMMUNODOT LYME TEST

K number K894410

LSR 1989-09-19

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM

Applicant Mardx, Inc.

K number K894609

LSR 1989-08-21

MARDX LYME DISEASE EIA (IGM) TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K894293

LSR 1989-08-21

MARDX LYME DISEASE EIA (IGG) TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K894224

LSR 1989-08-15

MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K892206

LSR 1989-07-25

LYME DISEASE MICROASSAY

Applicant Diamedix Corp.

K number K890843

LSR 1989-04-18

MARDX LYME DISEASE IGG IFA TEST SYSTEM

Applicant Mardx Diagnostics, Inc.

K number K890053

LSR 1989-04-10

BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM

Applicant Medical Diagnostic Technologies, Inc.

K number K885294