510(k) CLEARED PRODUCTS

The products on this list are cleared as medical devices by the US Food and Drug Administration for in vitro diagnostic use in the United States.
All other Hyphen-Biomed products are intended for research use only in US.


Code Name Price  
A223405 BIOPHEN Act. PC-r Control Plasma $243.00
A223301 BIOPHEN Abnormal Control Plasma - IVD $219.00
A221102 BIOPHEN Antithrombin 2.5 $124.00
A221105 BIOPHEN Antithrombin 5 $385.00
A221003 BIOPHEN Heparin 3 $243.00
A221006 BIOPHEN Heparin 6 $559.00
A222001 BIOPHEN Heparin Calibrator $341.00
A223801 BIOPHEN LMWH Control C3 $219.00
A224201 BIOPHEN LMWH Control C4 $219.00
A223701 BIOPHEN LMWH Control Low $219.00
A224301 BIOPHEN LMWH Control Low Cl $219.00
A224401 BIOPHEN LMWH Control Low Cll $219.00
A223001 BIOPHEN LMWH Control Plasma $219.00
A222101 BIOPHEN Plasma Calibrator - IVD $436.00
A221205 BIOPHEN Protein C 5 $864.00
A222301 BIOPHEN UFH Calibrator $341.00
A224101 BIOPHEN UFH Control C1 $219.00
A223901 BIOPHEN UFH Control C2 $219.00
A223101 BIOPHEN UFH Control Plasma $219.00
ACK065K HEMOCLOT Quanti-V-L $280.00