Alere Shanghai Diagnostics Co L T D

FDA Filings

This page includes the latest FDA filings for Alere Shanghai Diagnostics Co 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 Number3005128563
FEI Number3005128563
NameALERE (SHANGHAI) DIAGNOSTICS CO., LTD.
Owner & OperatorAbbott
Contact Address100 Abbott Park Building J49
Abbott Park IL 60064 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNO. 151 LIBING ROAD No. 3728, JINKE ROAD
SHANGHAI Shanghai, 201203 CN
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Early Detection Pregnancy Test2016-07-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital Prueba de Embarazo2016-07-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital & Rapid Detection Pregnancy Test2016-07-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Advanced Fertility Monitor2016-07-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Advanced Fertility Monitor Pregnancy Test Sticks2016-07-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Advanced Digital Pregnancy Test2016-07-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Advanced Pregnancy Test with Weeks Estimator2013-01-24
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Visual Preg Test2011-12-01
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Pregnancy Planning Kit2011-12-01
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital and Visual Pregnancy Kit2011-12-01
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Target Digital Ovulation2009-12-15
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital Ovulation2009-12-15
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Advanced Ovulation2009-12-15
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Fertility Monitor2008-03-10
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Fertility Monitor Sticks2008-03-10
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Fertility Monitor2008-03-10
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Fertility Monitor Sticks2008-03-10
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walmart Equate Early Ovulation2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Preg Planning Kit2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Connected Ovulation Test System2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue +/- Ovulation and Digital Pregnancy2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue +/- Ovulation Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walgreens Digital Early Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Topcare Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Target Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Signature Care Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shoppers Drug Mart Digital Early and Visual Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Rite Aid Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
HEB Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Equaline Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital Preg and Visual Ovulation Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
CVS Yes/No Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
CVS Digital Early Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Winco Foods Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Winco Foods +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Western Family Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Western Family +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walmart Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walmart Equate Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walmart Equate +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walgreens Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walgreens Early Pregnancy Bilingual Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walgreens +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Topcare Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Topcare +/- Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Target Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Target +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Sunmark Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Sunmark +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Signature Care Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shur Fine +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shopko Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shopko Early Pregnancy Bilingual Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shopko +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shop Rite Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Shop Rite +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Select Brand +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
SDM Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
SDM +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Rite Aid Early Pregnancy Bilingual Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Rite Aid +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Quality Choice Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Quality Choice +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Publix +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Price Chopper Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Premier Value Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Premier Value +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Preferred Plus Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Preferred Plus One Step Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Preferred Plus +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Pharmasave Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Pharmasave +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Metro Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Meijer Visual Early Preg test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Meijer +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
London Drug +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Loblaws Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Loblaws +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Leader Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Leader +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Kroger Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Kroger +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Kmart Smart Sense Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Kmart Image Essentials +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Hy-Vee Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Hy-Vee +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Healthy Accents +/- Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Health Mart Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Health Mart +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
HEB Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
HEB Bi-Ling Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
HEB +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Good Sense Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Good Sense +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Good Neighbor Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Good Neighbor +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Generic +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Family Dollar Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Familiprix Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Familiprix +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Fact Plus +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Exchange Select Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Exchange Select +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Equaline Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Equaline +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Dollar General +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Discount Drug Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Discount Drug +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Care One +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
CVS Visual Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
CVS Early Bi-Ling Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
CVS +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Best Choice Early Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Best Choice +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Accuclear +/- Preg Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue +/- Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Clearblue Digital Pregnancy Test2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Inv Med Early Preg Test Cassette2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Inv Medical Early Preg Test Wd Wick2007-11-13
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Early Ovulation Predictor Cassette, One Step2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Walgreens Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Topcare Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Target Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
SDM Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Rite Aid Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Leader Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Kroger Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
HEB Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Good Neighbor Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
Exchange Select Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
CVS Visual Ovulation Test2006-01-31
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
e.p.t. Digital Early Pregnancy Test2005-04-19
ALERE (SHANGHAI) DIAGNOSTICS CO., LTD. [Abbott]
e.p.t. Early Pregnancy Test2005-04-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201804048Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyPREGNANCY TEST STICKS2310 CTN
201804048Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyPREGNANCY TEST STICKS2310 CTN
201804048Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyPREGNANCY TEST STICKS2310 CTN

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