Gordon Ens

FDA Filings

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

FDA Registration(s)
Registration Number8043599
FEI Number3005917516
NameGordon Ens
Owner & OperatorPrecision BioLogic
Contact Address140 Eileen Stubbs Avenue
Dartmouth CA-NS Nova Scotia B3B 0A9 CA
Official Correspondent
  • Karen Black
  • 1-902-7063125-x
US Agent
Importing Logistics Registration
ImporterFedEx Trade Networks
Address3800 Forest Hill-Irene Road
Hickory Hill, TN 38125 UNITED STATES
Importer TypeBroker
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address224 Cedar Ridge Ct
Andover, KS 67002 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Gordon Ens [Precision BioLogic]
Cryocheck Lupus Negative Control2020-02-24
Gordon Ens [Precision BioLogic]
CRYOCHECK FVIII Inhibitor Kit2019-03-15
Gordon Ens [Precision BioLogic]
CRYOCHECK FVIII Inhibitor Kit2019-03-15
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor II Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK LA Sure2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK LA Check2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Prekallikrein Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Platelet Lysate2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor XII Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor XI Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor X Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor IX Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor VIII Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor VII Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Factor V Deficient Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK APCR Positive Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Abnormal 2 Reference Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Abnormal 1 Reference Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Abnormal 2 Reference Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Abnormal 1 Reference Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Lupus Positive Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Lupus Positive Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Normal Reference Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Low Fibrinogen Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Pooled Normal Plasma2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Abnormal 2 Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Abnormal 1 Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Clot S2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Clot C2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Weak Lupus Positive Control2007-12-04
Gordon Ens [Precision BioLogic]
CRYOCHECK Reference Control Normal2007-12-04

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