ClearanceBrief
Panels › Microbiology › Product code LSR · Class 2

Reagent, Borrelia Serological Reagent

Regulation 866.3830

2510(k)s in 12 months (112 all time)
1recalls in 12 months (5 all time)
2recalls that name a 510(k)
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Top companies in LSR

Company510(k)sRecalls
Zeus Scientific130
Gold Standard Diagnostics90
Viramed Biotech AG70
Mardx Diagnostics, Inc.60
Biomerieux S.A.23
Boston Biomedica, Inc.40
Diamedix Corp.40
DiaSorin, Inc.40
General Biometrics, Inc.40
Hillcrest Biologicals40
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Lyme Test
Open, Classified		 LSRNone listed
Sep 22, 2021bioMerieux, Inc.
VIDAS Lyme IgG II (LYM), REF 417401
Open, Classified		 LSRNone listed
Sep 22, 2021bioMerieux, Inc.
VIDAS Lyme IgM II (LYM), REF 416436
Open, Classified		 LSRNone listed
Mar 8, 2013Innominata Dba Genbio
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manuf
Terminated		 LSRK911590
Jul 20, 2004Biomerieux, Inc.
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml
Terminated		 LSRK943812

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