Bio-Rad Laboratories - FDA 510(k) Cleared Devices

Cleared Mar 12, 2019

BioPlex 2200 Lyme Total

K183446 · LSR

Microbiology · 90d

Cleared May 19, 2017

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200...

K170509 · PUQ

Microbiology · 87d

Cleared May 11, 2017

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR...

K170413 · LIP

Microbiology · 90d

Cleared May 10, 2016

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek...

K152679 · PMN

Microbiology · 235d

Not Cleared Mar 28, 2016

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II,...

DEN150058 · PMN

Microbiology · 103d

Cleared Nov 02, 2012

BIOPLEX 2200 EBV IGM KIT

K123021 · LJN

Microbiology · 36d

Cleared Jun 22, 2012

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

K120959 · MXJ

Microbiology · 84d

Cleared Aug 23, 2011

BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...

K111072 · OPL

Microbiology · 127d

Cleared Dec 03, 2010

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE...

K092587 · LFX

Microbiology · 466d

Cleared Mar 29, 2010

BIOPLEX 2200 MMRV IGG

K091616 · OPL

Microbiology · 299d

Cleared Jul 01, 2009

PLATELIA TOXO IGM KIT MODEL 26211

K090847 · LGD

Microbiology · 93d

Cleared May 08, 2009

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...

K090409 · MXJ

Microbiology · 79d