DiaSorin, Inc. - FDA 510(k) Cleared Devices

Cleared Apr 12, 2007

LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870

K062473 · LSR

Microbiology · 231d

Cleared Feb 26, 2007

DIASORIN LIAISON VZV IGG

K061820 · LFY

Microbiology · 243d

Cleared Oct 18, 2006

LIAISON EA IGG

K060204 · LSE

Microbiology · 265d

Cleared Jul 31, 2006

DIASORIN LIAISON TREPONEMA ASSAY

K061247 · LIP

Microbiology · 89d

Cleared Mar 31, 2006

ETI-MAX 3000

K052794 · JJF

Immunology · 179d

Cleared Apr 29, 2005

DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS

K040120 · LLM

Microbiology · 465d

Cleared Jul 14, 2004

TSH-CTK-3 IRMA

K041014 · JLW

Chemistry · 85d

Cleared Feb 12, 2004

LIAISON 25 OH VITAMIN D

K032844 · MRG

Chemistry · 154d

Cleared Feb 12, 2004

LIAISON N-TACT PTH

K033426 · CEW

Chemistry · 108d

Cleared Mar 26, 2002

1,25-DIHYDROXYVITAMIN D125I RIA

K014030 · MRG

Chemistry · 110d

Cleared Apr 25, 2000

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

K001118 · DFC

Chemistry · 18d

Cleared Feb 10, 2000

COPALIS RUBELLA IGM

K993291 · LFX

Microbiology · 132d

Cleared Dec 16, 1999

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY

K992552 · LIP

Microbiology · 139d

Cleared Nov 17, 1999

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

K993669 · DFC

Chemistry · 16d

Cleared Jul 12, 1999

ETI-EA-G ASSAY

K992191 · LSE

Microbiology · 14d

Cleared Jun 04, 1999

COPALIS MULTIPLEX EBV ANTIBODY ASSAY

K991660 · LSE

Microbiology · 21d

Cleared May 14, 1999

COPALIS EBV-M ANTIBODY ASSAY

K991459 · LJN

Microbiology · 18d

Cleared Apr 02, 1999

SPQ TEST SYSTEM

K982708 · DFC

Chemistry · 241d

Cleared Dec 18, 1998

TRANSFERRIN SPQ III ANTIBODY REAGENT SET

K983880 · DDG

Immunology · 46d

Cleared Nov 25, 1998

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

K982027 · LFZ

Microbiology · 176d

Cleared Nov 16, 1998

25-HYDROXYVITAMIN D 125I RIA KIT

K983617 · LCI

Chemistry · 32d