Omega Bio-tek
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000024148 FEI 3014290238
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
MBFit24™ Blood & Tissue DNA Kit CE IVD Ref B6399-5-48PFCEIVD
Regimes: CE IVDR Registry: EUDAMEDMag-Bind® Viral DNA/RNA Xpress Kit CE IVD Ref M6219-2304CEIVD
Regimes: CE IVDR Registry: EUDAMEDMBFit24™ cfDNA Kit CE IVD Ref B3298-10-48PFCEIVD
Regimes: CE IVDR Registry: EUDAMEDMag-Bind® cfDNA Kit CE IVD Ref M3298-02CEIVD
Regimes: CE IVDR Registry: EUDAMEDMag-Bind® cfDNA Kit CE IVD Ref M3298-01CEIVD
Regimes: CE IVDR Registry: EUDAMEDMag-Bind® Blood DNA HV Kit CE IVD Ref M3292-03CEIVD
Regimes: CE IVDR Registry: EUDAMEDMagBinder® Fit24 Ref B1-001-24CEIVD
Regimes: CE IVDR Registry: EUDAMEDMag-Bind® Blood & Tissue DNA Kit CE IVD Ref M6399-01CEIVD
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000024148
- FDA FEI number
- 3014290238
- EUDAMED status
- Active
- EUDAMED registered name
- Omega Bio-tek
- Registered address
- 400, Pinnacle Way, 30071, Norcross, United States
- Website
- www.omegabiotek.com
- facebook.com/omegabiotek
- [email protected]
- Phone
- +1 770 931-8400
- PRRC contact
- Richard Blomgren
From the company website
Delivering Solutions in DNA and RNA Purification Delivering Solutions in DNA and RNA Purification “The Mag-Bind® Endo-free Plasmid Midi Kit is an excellent product for midi prep plasmid extraction. We routinely recover around 70 µg of DNA from 10ml of culture, and the magnetic bead workflow without automated liquid handlers takes about half the time \[…\]
Frequently asked questions
How many devices does Omega Bio-tek have in the registry?
The registry currently lists 8 devices for Omega Bio-tek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Bio-tek's devices?
Among its 8 most recently registered devices, Omega Bio-tek has devices listed in EUDAMED (8 devices).
What risk classes do Omega Bio-tek's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Omega Bio-tek's devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Omega Bio-tek in the registry?
The most recently registered devices listed for Omega Bio-tek include MBFit24™ Blood & Tissue DNA Kit CE IVD, Mag-Bind® Viral DNA/RNA Xpress Kit CE IVD, MBFit24™ cfDNA Kit CE IVD and Mag-Bind® cfDNA Kit CE IVD.