Data / Medical devices / France / Hyphen Biomed Sasu
Hyphen Biomed Sasu: FDA-registered device maker in NEUVILLE SUR OISE Val-d'Oise, France, 7 510(k) clearances
Hyphen Biomed Sasu is registered with the FDA (registration 3004434070) in NEUVILLE SUR OISE Val-d'Oise, France. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 8, 2009. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004434070
- Address
- 155 Rue D Eragny, NEUVILLE SUR OISE Val-d'Oise, France, 95000
- Owner or operator
- HYPHEN BIOMED (9067801)
- Roles
- Manufacturer
- First device listed
- June 18, 2007
- Registered through
- 2026
- Brand names listed
- AR001B Calcium Chloride 025M (M/40) 3X15ml, AR001K Calcium chloride 0,025M (M/40) Set of 12x25 ml, AR001L Calcium Chloride 025M (M/40) 12x15ml, AR021B Imidazole buffer 1x15ml, AR021K Imidazole buffer 3x25 ml, AR021L Imidazole buffer 12x25 ml, AR021M Imidazole buffer 3x15ml, AR021N Imidazole buffer 12x15ml and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antithrombin Iii Quantitation | JBQ | 2 | Manufacturer | accessdata.fda.gov |
| Assay, Heparin | KFF | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Control, Plasma, Abnormal | GGC | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Ph Buffer | JCC | 1 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Manufacturer | accessdata.fda.gov |
| Platelet Factor 4 Radioimmunoassay | LCO | 2 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Partial Thromboplastin | GGW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2009 | K083729 | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN | GGW | Substantially Equivalent | Aniara Diagnostica, LLC | accessdata.fda.gov |
| September 7, 2007 | K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | LCO | Substantially Equivalent | Hyphen Biomed | accessdata.fda.gov |
| May 24, 2006 | K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | KFF | Substantially Equivalent | Hyphen Biomed | accessdata.fda.gov |
| December 27, 2005 | K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | GGP | Substantially Equivalent | Hyphen Biomed | accessdata.fda.gov |
| December 23, 2005 | K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | GGN | Substantially Equivalent | Hyphen Biomed | accessdata.fda.gov |
| November 7, 2005 | K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | JBQ | Substantially Equivalent | Hyphen Biomed | accessdata.fda.gov |
| March 17, 2005 | K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | GGN | Substantially Equivalent | Hyphen Biomed | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 5, 2018 | 79797 | Class II | Terminated | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is inte | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. | accessdata.fda.gov |
| November 9, 2011 | 79269 | Class II | Terminated | ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests. | A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results. | accessdata.fda.gov |
Compare with other makers
- All makers of General Purpose Reagent
- All makers of Test, Qualitative And Quantitative Factor Deficiency
- All makers of Platelet Factor 4 Radioimmunoassay
- All makers of Assay, Heparin
- All makers of Ph Buffer
- All makers of Plasma, Coagulation Control
Updated May 8, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.