Premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
| Reference | Product Name | Price | ||
|
|
221003
|
BIOPHEN™ Heparin 3 | Discontinued | |
|
|
221006
|
BIOPHEN™ Heparin 6 | $933.18 | |
|
|
221102
|
BIOPHEN™ Antithrombin 2.5 | $132.87 | |
|
|
221105
|
BIOPHEN™ Antithrombin 5 | $477.92 | |
|
|
221205
|
BIOPHEN™ Protein C 5 | $1,166.99 | |
|
|
RK040A
|
ZYMUTEST™ HIA IgG | $965.11 | |
|
|
RK040D
|
ZYMUTEST™ HIA IgGAM | $965.11 | |
|
|
RK041A
|
ZYMUTEST™ HIA MonoStrip IgG | $530.45 | |
|
|
RK041D
|
ZYMUTEST™ HIA MonoStrip IgGAM | Discontinued | |
|
|
CK065K
|
HEMOCLOT™ Quanti-V-L | $371.83 | |
|
|
222401
|
BIOPHEN™ V-L Plasma Calibrator | $148.32 | |
|
|
222001
|
BIOPHEN™ Heparin Calibrator | $584.01 | |
|
|
222301
|
BIOPHEN™ UFH Calibrator | $572.68 | |
|
|
222101
|
BIOPHEN™ Plasma Calibrator | $732.33 | |
|
|
223201
|
BIOPHEN™ Normal Control Plasma (IVD) | $371.83 | |
|
|
223001
|
BIOPHEN™ LMWH Control Plasma | $371.83 | |
|
|
223101
|
BIOPHEN™ UFH Control Plasma | $371.83 | |
|
|
223405
|
BIOPHEN™ V-L Control Plasma | $265.74 | |
|
|
223701
|
BIOPHEN™ LMWH Control Low | $371.83 | |
|
|
223801
|
BIOPHEN™ LMWH Control C3 | $371.83 |