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 | ||
|
|
A221006
|
BIOPHEN™ Heparin 6 | $439.00 | |
|
|
A221102
|
BIOPHEN™ Antithrombin 2.5 | $92.00 | |
|
|
A221105
|
BIOPHEN™ Antithrombin 5 | Price Inquiry | |
|
|
A221205
|
BIOPHEN™ Protein C 5 | $714.00 | |
|
|
ARK040A
|
ZYMUTEST™ HIA IgG | $999.00 | |
|
|
ARK040D
|
ZYMUTEST™ HIA IgGAM | $999.00 | |
|
|
ARK041A
|
ZYMUTEST™ HIA MonoStrip IgG | $549.00 | |
|
|
ACK065K
|
HEMOCLOT™ Quanti-V-L | $385.00 | |
|
|
A222401
|
BIOPHEN™ V-L Plasma Calibrator | $102.00 | |
|
|
A222001
|
BIOPHEN™ Heparin Calibrator | $245.00 | |
|
|
A222301
|
BIOPHEN™ UFH Calibrator | $255.00 | |
|
|
A222101
|
BIOPHEN™ Plasma Calibrator | $318.00 | |
|
|
A223201
|
BIOPHEN™ Normal Control Plasma (IVD) | $175.00 | |
|
|
A223001
|
BIOPHEN™ LMWH Control Plasma | $175.00 | |
|
|
A223101
|
BIOPHEN™ UFH Control Plasma | $175.00 | |
|
|
A223405
|
BIOPHEN™ V-L Control Plasma | $175.00 | |
|
|
A223701
|
BIOPHEN™ LMWH Control Low | $175.00 | |
|
|
A223801
|
BIOPHEN™ LMWH Control C3 | $175.00 | |
|
|
A223901
|
BIOPHEN™ UFH Control C2 | $175.00 | |
|
|
A224401
|
BIOPHEN™ LMWH Control Low Cll | $175.00 |