Axis Shield Diagnostics L T D

FDA Filings

This page includes the latest FDA filings for Axis Shield Diagnostics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8032314
• FEI Number: 3002808140
• Name: Leanne Kiviharju
• Owner & Operator: AXIS-SHIELD DIAGNOSTICS, LTD.
• Contact Address: LUNA PLACE THE TECHNOLOGY PARK; DUNDEE, SCOTLAND GB-UKM United Kingdom DD2 1XA GB
• Official Correspondent:
  • CLAIRE - DORA
  • 044-1382-422000-232
• US Agent:
  • Leanne Kiviharju
  • Abbott
  • 858 8052227
  • 858 2818546
  • leanne.kiviharju@alere.com
• Importing Logistics Registration:
  • Importer: Biopacific Diagnostic Corp
  • Address: 4305 143 Place NE ; Bellevue, WA 98007 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: IBL-America
  • Address: 8201 Central Ave NE Suite P ; Fridley, MN 55432 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9975 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

FDA Filings

Device Company	Device	Date
PMN K183088 | GGT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ADVIA Centaur Erythropoietin (EPO) Assay (XP)	2019-08-26
PMN K183088 Axis-Shield Diagnostics Limited	ADVIA Centaur Erythropoietin (EPO) Assay	2019-08-02
PMN K182012 | JKR Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ADVIA Centaur? Calcitonin (CALCT) assay	2019-01-07
PMN K182012 Axis-Shield Diagnostics Limited	ADVIA Centaur Calcitonin (CALCT) Assay	2018-12-21
JJY Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity I Anti-CCP Controls	2018-11-13
JJY Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alere Cholestech Calibration Verification; Alere Cholestech Multianalyte Controls; Alere Cholestech Multianalyte Control	2018-11-13
JJY Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ARCHITECT Anti-CCP Controls	2018-11-13
JIX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity I Anti-CCP Calibrators	2018-11-13
JIX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ARCHITECT Anti-CCP Calibrators	2018-11-13
GUDID 05055845400282 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine FHBC100/B08176	2018-07-06
GUDID 05055845400183 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine FHRWR1000	2018-07-06
GUDID 05055845400176 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine FHRWR200	2018-07-06
GUDID 05055845400169 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine FHRWR100	2018-07-06
GUDID 05055845400084 AXIS-SHIELD DIAGNOSTICS LIMITED	3-Reagent Homocysteine Assay for SYNCHRON UniCel FHYB100/B08175	2018-07-06
GUDID 05055845400046 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Active-B12 (Holotranscobalamin) EIA FMABT100	2018-07-06
GUDID 05055845400022 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Homocysteine Controls FHCY200	2018-07-06
GUDID 05055845400015 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis® Homocysteine EIA FHCY100	2018-07-06
GUDID 05055845400008 AXIS-SHIELD DIAGNOSTICS LIMITED	Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptid FCCP600	2018-07-06
JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity i Active-B12 (Holotranscobalamin) Controls	2018-06-29
JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity I 2nd Generation Testosterone Controls	2018-06-29
JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity i Active-B12 (Holotranscobalamin) Calibrators	2018-06-29
JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity I 2nd Generation Testosterone Calibrators	2018-06-29
PMN K172133 | CDD Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay	2018-01-08
PMN K172133 Axis-Shield Diagnostics Ltd.	ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay	2017-10-27
PMN K150358 | GMQ Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	2017-05-23
PMN K153551 | NHX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ADVIA Centaur anti-CCP (aCCP) assay	2016-08-08
PMN K153551 | NHX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ADVIA Centaur anti-CCP (aCCP) Quality Controls	2016-08-08
PMN K153551 | NHX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ADVIA Centaur anti-CCP (aCCP) Master Curve Materials (MCM)	2016-08-08
PMN K153551 Axis-Shield Diagnostics Limited.	ADVIA Centaur Anti-CCP IgG (aCCP) Assay Including Reagents And Calibrators, Quality Controls And Master Curve Materials.	2016-08-04
PMN K160757 AXIS-SHIELD DIAGNOSTICS LIMITED	ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, And ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)	2016-07-26
PMN K152155 | CDZ Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity i 2nd Generation Testosterone Reagent Kit	2016-07-13
PMN K152155 | CDZ Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ARCHITECT 2nd Generation Testosterone	2016-07-13
PMN K121946 | CDD Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	IBL International GmbH Active-B12 (Holotranscobalamin) ELISA	2013-05-14
PMN K121946 | CDD Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Axis-Shield Active-B12 (Holotranscobalmin)	2013-05-14
PMN K121946 AXIS-SHIELD DIAGNOSTICS, LTD.	AXIS-SHIELD ACVTIVE-B12	2013-03-22
PMN K121842 | LCP Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT HbA1c	2013-01-11
PMN K121842 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT HbA1c	2013-01-11
PMN K061588 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Ortho Clinical Diagnostics Vitros Homocysteine	2013-01-11
PMN K061588 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Ortho Clinical Diagnostics Vitros Homocysteine	2013-01-11
PMN K061588 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Ortho Clinical Diagnostics Vitros Homocysteine	2013-01-11
PMN K121842 AXIS-SHIELD DIAGNOSTICS, LTD.	ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C	2012-12-12
PMN K120009 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT 2nd Generation Testosterone	2012-09-20
PMN K120009 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT 2nd Generation Testosterone	2012-09-20
PMN K120009 | CDZ Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT 2nd Generation Testosterone	2012-09-20
PMN K112790 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	3-Reagent Homocysteine Assay for SYNCHRON and UniCel	2012-06-19
PMN K112790 AXIS-SHIELD DIAGNOSTICS, LTD.	AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON	2012-05-07
PMN K112443 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity i Active-B12 (Holotranscobalamin)	2012-01-16
PMN K112443 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)	2012-01-16
PMN K112443 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity i Active-B12 (Holotranscobalamin)	2012-01-16
PMN K112443 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)	2012-01-16
PMN K112443 | CDD Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Alinity i Active-B12 (Holotranscobalamin)	2012-01-16
PMN K112443 | CDD Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)	2012-01-16
PMN K110296 | NHX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS-SHIELD ANTI-CCP	2011-12-21
PMN K112443 AXIS-SHIELD DIAGNOSTICS, LTD.	ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)	2011-12-19
PMN K110296 AXIS-SHIELD DIAGNOSTICS, LTD.	AXIS-SHIELD ANTI-CCP	2011-08-18
PMN K083868 | NHX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Anti-CCP	2009-10-20
PMN K083868 | JJY Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Anti-CCP	2009-10-20
PMN K083868 | JIX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Anti-CCP	2009-10-20
PMN K083868 AXIS-SHIELD DIAGNOSTICS, LTD.	ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35	2009-09-25
PMN K083222 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Sekisui Diagnostics	2009-09-07
PMN K083222 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Gold Standard	2009-09-07
PMN K083222 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Carolina Liquid Chemistries	2009-09-07
PMN K083222 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Sekisui Diagnostics	2009-09-07
PMN K083222 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Gold Standard	2009-09-07
PMN K083222 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Carolina Liquid Chemistries	2009-09-07
PMN K083222 AXIS-SHIELD DIAGNOSTICS, LTD.	AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100	2009-07-31
PMN K073640 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Homocysteine	2008-04-28
PMN K073640 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Homocysteine	2008-04-28
PMN K073640 | JIT Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	ABBOTT ARCHITECT Homocysteine	2008-04-28
PMN K073640 AXIS-SHIELD DIAGNOSTICS, LTD.	ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS	2008-04-24
PMN K072686 AXIS-SHIELD DIAGNOSTICS, LTD.	AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS	2008-03-17
PMN K063347 AXIS-SHIELD DIAGNOSTICS, LTD.	AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10	2007-03-20
PMN K062467 AXIS-SHIELD DIAGNOSTICS, LTD.	AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10	2006-11-22
PMN K980907 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Axis? Homocysteine EIA	2004-04-26
PMN K980907 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS SHIELD HOMOCYSTEINE	2004-04-26
PMN K980907 | LPS Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS SHIELD HOMOCYSTEI	2004-04-26
PMN K980907 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Axis? Homocysteine EIA	2004-04-26
PMN K980907 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS SHIELD HOMOCYSTEINE	2004-04-26
PMN K980907 | JJX Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS SHIELD HOMOCYSTEI	2004-04-26
PMN K980907 | DFC Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	Axis? Homocysteine EIA	2004-04-26
PMN K980907 | DFC Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS SHIELD HOMOCYSTEINE	2004-04-26
PMN K980907 | DFC Leanne Kiviharju [AXIS-SHIELD DIAGNOSTICS, LTD.]	AXIS SHIELD HOMOCYSTEI	2004-04-26
PMN K033606 AXIS-SHIELD DIAGNOSTICS, LTD.	ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST	2004-01-30
PMN K023285 AXIS-SHIELD DIAGNOSTICS, LTD.	DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA	2002-10-09
PMN K020687 AXIS-SHIELD DIAGNOSTICS, LTD.	DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300	2002-05-02
PMN K020349 AXIS-SHIELD DIAGNOSTICS, LTD.	ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS	2002-05-02
PMN K020348 AXIS-SHIELD DIAGNOSTICS, LTD.	ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS	2002-05-02

Related Finance Registrations

NCAGE Code	U8163	AXIS-SHIELD DIAGNOSTICS LTD
CAGE Code	U8163	AXIS-SHIELD DIAGNOSTICS LTD