This page includes the latest FDA filings for Precision Biologic. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 8043599 | ||||||
| FEI Number | 3005917516 | ||||||
| Name | Gordon Ens | ||||||
| Owner & Operator | Precision BioLogic | ||||||
| Contact Address | 140 Eileen Stubbs Avenue Dartmouth CA-NS Nova Scotia B3B 0A9 CA | ||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | 224 Cedar Ridge Ct Andover, KS 67002 US | ||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
Precision BioLogic | Cryocheck Hex LA | 2020-10-23 |
Precision BioLogic | Cryocheck Chromogenic Factor VIII | 2020-07-17 |
Gordon Ens [Precision BioLogic] | Cryocheck Lupus Negative Control | 2020-02-24 |
Gordon Ens [Precision BioLogic] | CRYOCHECK FVIII Inhibitor Kit | 2019-03-15 |
Gordon Ens [Precision BioLogic] | CRYOCHECK FVIII Inhibitor Kit | 2019-03-15 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor II Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK LA Sure | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK LA Check | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Prekallikrein Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Platelet Lysate | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor XII Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor XI Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor X Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor IX Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor VIII Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor VII Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Factor V Deficient Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK APCR Positive Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Abnormal 2 Reference Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Abnormal 1 Reference Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Abnormal 2 Reference Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Abnormal 1 Reference Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Lupus Positive Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Lupus Positive Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Normal Reference Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Low Fibrinogen Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Pooled Normal Plasma | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Abnormal 2 Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Abnormal 1 Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Clot S | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Clot C | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Weak Lupus Positive Control | 2007-12-04 |
Gordon Ens [Precision BioLogic] | CRYOCHECK Reference Control Normal | 2007-12-04 |
PRECISION BIOLOGIC | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | 2003-11-03 |
PRECISION BIOLOGIC | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | 2003-04-28 |
PRECISION BIOLOGIC | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | 2001-12-10 |
PRECISION BIOLOGIC | CRYOCHECK LA SURE, MODEL SUR25-10 | 1999-07-28 |
PRECISION BIOLOGIC | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | 1999-07-23 |
PRECISION BIOLOGIC | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | 1999-06-07 |
PRECISION BIOLOGIC | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | 1999-03-18 |