Idexx Laboratories Inc

FDA Filings

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

USANASDAQIDXXDUNS 108183757
FDA Registration(s)
Registration Number3004102403
FEI Number3004102403
NameOPTI MEDICAL SYSTEMS INC.
Owner & OperatorIDEXX LABORATORIES INC.
Contact AddressONE IDEXX DR. --
Westbrook ME 04092 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address235 Hembree Park Dr
ROSWELL, GA 30076 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS22013-08-27
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS B-Lac2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
CCA-TS B-Lac Cassette2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS B-Lac2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
CCA-TS B-Lac Cassette2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS B-Lac2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
CCA-TS B-Lac Cassette2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS B-Lac2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
CCA-TS B-Lac Cassette2011-02-17
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Rhythm2008-07-29
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Rhythm Plus2008-07-29
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Rhythm Peds2008-07-29
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI-Check2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Check2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI-Check Lytes2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Check Lytes2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI R Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Lion2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI LION Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Lion2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI LION Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Lion2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI LION Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Lion2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI LION Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Lion2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI LION Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Lion2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI LION Analyzer2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI-Check Plus2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Check PLUS2007-12-08
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Urea Glucose2007-03-06
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-03-06
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-03-06
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Urea Glucose2007-03-06
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA-TS Analyzer2007-03-06
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI CCA Analyzer2007-03-06
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
OPTI Comfort Sampler2004-04-14
OPTI MEDICAL SYSTEMS INC. [IDEXX LABORATORIES INC.]
Comfort Sampler2004-04-14

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092866140Reykjavik,Iceland -> Portland, Maine1 X 40'FLAT LCL/FCL CONTAINER: 2 CRATES CARTO NING MACHINE CP500 NO 7620184 PKG
2020092866140Reykjavik,Iceland -> Portland, Maine1 X 40'FLAT LCL/FCL CONTAINER: 1 CRATE CARTON ING MACHINE4 PKG
2020091956248Ningpo ,China (Mainland) -> Long Beach, CaliforniaPS VESSEL840 CTN
202009194438Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyFAULTY INSTRUMENT17 CTN
2020091956347Ningpo ,China (Mainland) -> Long Beach, CaliforniaPS VESSEL840 CTN
2020091956319Ningpo ,China (Mainland) -> Long Beach, CaliforniaFECAL TUBE882 CTN
2020091956330Ningpo ,China (Mainland) -> Long Beach, CaliforniaSAMPLE CUP360 CTN
2020091956282Ningpo ,China (Mainland) -> Long Beach, CaliforniaPS VESSEL405 CTN

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