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  
A222401 BIOPHEN V-L CAL (undiluted) $156.00
ARK040A ZYMUTEST HIA IgG $615.00
ARK040D ZYMUTEST HIA IgGAM $615.00
ARK041A ZYMUTEST HIA Mono Strip IgG $297.00
ARK041D ZYMUTEST HIA Mono strip IgGAM $297.00
A223201 BIOPHEN Normal Control Plasma - IVD $219.00