Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 26, 2022

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

K220262 · PRI

Microbiology · 207d

Cleared Jul 17, 2019

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur...

K191578 · QFO

Microbiology · 33d

Cleared Jul 30, 2018

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

K181213 · LFZ

Microbiology · 84d

Cleared Jul 16, 2018

Atellica IM BRAHMS Procalcitonin (PCT)

K181002 · PMT

Microbiology · 91d

Cleared Oct 13, 2016

ADVIA Centaur HAV IgM Assay

K161964 · LOL

Microbiology · 87d

Cleared Dec 22, 2015

ADVIA Centaur Toxoplasma M (Toxo M)

K142826 · LGD

Microbiology · 448d

Cleared Jul 02, 2015

MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)

K150039 · LTT

Microbiology · 174d

Cleared Dec 05, 2014

ADVIA Centaur HAV total assay

K142758 · LOL

Microbiology · 71d

Cleared Aug 19, 2014

IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL

K141772 · JJX

Microbiology · 49d

Cleared Mar 14, 2013

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE

K123933 · LTT

Microbiology · 84d

Cleared Jan 20, 2012

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS

K112343 · LIP

Microbiology · 158d

Cleared Aug 04, 2011

MICROSCAN(R) MICROSTREP PLUS(R)

K111677 · LRG

Microbiology · 50d

Cleared Jul 20, 2011

MICROSCAN (R) MICROSTREP PLUS (R) PANELS

K111205 · LRG

Microbiology · 82d

Cleared Jun 22, 2011

MICROSCAN MICROSTEP

K111394 · LTT

Microbiology · 35d

Cleared May 04, 2011

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)

K102681 · LGD

Microbiology · 229d

Cleared Jul 17, 2008

ADVIA CENTAUR HAVM ASSAY

K081716 · LOL

Microbiology · 29d