Leanne Kiviharju

FDA Filings

This page includes the latest FDA filings for Leanne Kiviharju. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8032314
FEI Number3002808140
NameLeanne Kiviharju
Owner & OperatorAXIS-SHIELD DIAGNOSTICS, LTD.
Contact AddressLUNA PLACE THE TECHNOLOGY PARK
DUNDEE, SCOTLAND GB-UKM United Kingdom DD2 1XA GB
Official Correspondent
  • CLAIRE - DORA
  • 044-1382-422000-232
US Agent
Importing Logistics Registration
ImporterBiopacific Diagnostic Corp
Address4305 143 Place NE
Bellevue, WA 98007 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterIBL-America
Address8201 Central Ave NE Suite P
Fridley, MN 55432 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9975 Summers Ridge Road San Diago
San Diego, CA 92121 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Foreign Private Label Distributor

Registration Number9613069
FEI Number3003045237
NameLeanne Kiviharju
Owner & OperatorAbbott
Contact Address100 Abbott Park Building J49
Abbott Park IL 60064 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9975 Summers Ridge Road
San Diego, CA 92121 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ADVIA Centaur Erythropoietin (EPO) Assay (XP)2019-08-26
Leanne Kiviharju [Abbott]
Afinion HbA1c Dx2019-03-18
Leanne Kiviharju [Abbott]
Afinion HbA1c Dx2019-03-18
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ADVIA Centaur? Calcitonin (CALCT) assay2019-01-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity I Anti-CCP Controls2018-11-13
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alere Cholestech Calibration Verification; Alere Cholestech Multianalyte Controls; Alere Cholestech Multianalyte Control2018-11-13
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ARCHITECT Anti-CCP Controls2018-11-13
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity I Anti-CCP Calibrators2018-11-13
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ARCHITECT Anti-CCP Calibrators2018-11-13
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity i Active-B12 (Holotranscobalamin) Controls2018-06-29
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity I 2nd Generation Testosterone Controls2018-06-29
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity i Active-B12 (Holotranscobalamin) Calibrators2018-06-29
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity I 2nd Generation Testosterone Calibrators2018-06-29
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c2018-04-06
Leanne Kiviharju [Abbott]
Alere Afinion ACR2018-04-06
Leanne Kiviharju [Abbott]
Afinion HbA1c2018-04-06
Leanne Kiviharju [Abbott]
Afinion ACR2018-04-06
Leanne Kiviharju [Abbott]
Afinion 22018-04-06
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c2018-04-06
Leanne Kiviharju [Abbott]
Alere Afinion ACR2018-04-06
Leanne Kiviharju [Abbott]
Afinion HbA1c2018-04-06
Leanne Kiviharju [Abbott]
Afinion ACR2018-04-06
Leanne Kiviharju [Abbott]
Afinion 22018-04-06
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c2018-04-06
Leanne Kiviharju [Abbott]
Alere Afinion ACR2018-04-06
Leanne Kiviharju [Abbott]
Afinion HbA1c2018-04-06
Leanne Kiviharju [Abbott]
Afinion ACR2018-04-06
Leanne Kiviharju [Abbott]
Afinion 22018-04-06
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay2018-01-08
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System2017-05-23
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ADVIA Centaur anti-CCP (aCCP) assay2016-08-08
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ADVIA Centaur anti-CCP (aCCP) Quality Controls2016-08-08
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ADVIA Centaur anti-CCP (aCCP) Master Curve Materials (MCM)2016-08-08
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity i 2nd Generation Testosterone Reagent Kit2016-07-13
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ARCHITECT 2nd Generation Testosterone2016-07-13
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel Control2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel Control2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel Control2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel2014-05-06
Leanne Kiviharju [Abbott]
Alere Afinion Lipid Panel Control2014-05-06
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control I 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
HbA1c EQA Control CII 8x0,5 mL2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion AS100 Analyzer2013-11-21
Leanne Kiviharju [Abbott]
Alere Afinion ACR Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion HbA1c Control2013-11-21
Leanne Kiviharju [Abbott]
Afinion ACR Control2013-11-21
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
IBL International GmbH Active-B12 (Holotranscobalamin) ELISA2013-05-14
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Axis-Shield Active-B12 (Holotranscobalmin)2013-05-14
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT HbA1c2013-01-11
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT HbA1c2013-01-11
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Ortho Clinical Diagnostics Vitros Homocysteine2013-01-11
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Ortho Clinical Diagnostics Vitros Homocysteine2013-01-11
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Ortho Clinical Diagnostics Vitros Homocysteine2013-01-11
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT 2nd Generation Testosterone2012-09-20
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT 2nd Generation Testosterone2012-09-20
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT 2nd Generation Testosterone2012-09-20
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
3-Reagent Homocysteine Assay for SYNCHRON and UniCel2012-06-19
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity i Active-B12 (Holotranscobalamin)2012-01-16
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)2012-01-16
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity i Active-B12 (Holotranscobalamin)2012-01-16
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)2012-01-16
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Alinity i Active-B12 (Holotranscobalamin)2012-01-16
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)2012-01-16
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS-SHIELD ANTI-CCP2011-12-21
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Anti-CCP2009-10-20
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Anti-CCP2009-10-20
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Anti-CCP2009-10-20
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Sekisui Diagnostics2009-09-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Gold Standard2009-09-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Carolina Liquid Chemistries2009-09-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Sekisui Diagnostics2009-09-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Gold Standard2009-09-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Carolina Liquid Chemistries2009-09-07
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Homocysteine2008-04-28
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Homocysteine2008-04-28
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
ABBOTT ARCHITECT Homocysteine2008-04-28
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Axis? Homocysteine EIA2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS SHIELD HOMOCYSTEINE2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS SHIELD HOMOCYSTEI2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Axis? Homocysteine EIA2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS SHIELD HOMOCYSTEINE2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS SHIELD HOMOCYSTEI2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
Axis? Homocysteine EIA2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS SHIELD HOMOCYSTEINE2004-04-26
Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]
AXIS SHIELD HOMOCYSTEI2004-04-26

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