Hyphen BioMed
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1744-2018 | Class II | ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended f | February 5, 2018 |
| Z-1743-2018 | Class II | ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-depe | February 5, 2018 |
| Z-1742-2018 | Class II | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for | February 5, 2018 |
| Z-1062-2018 | Class II | ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of hepari | November 9, 2011 |
| Z-1063-2018 | Class II | ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection | November 9, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | September 7, 2007 |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | May 24, 2006 |
| K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | December 27, 2005 |
| K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | December 23, 2005 |
| K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | November 7, 2005 |
| K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | March 17, 2005 |