FDA Registration
Active
🇺🇸 United States
OriGen Biomedical, Inc.
Reg #: 3042484745
·
FEI: 3042484745
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- OriGen Biomedical, Inc.
- Registration Number
- 3042484745
- FEI Number
- 3042484745
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2215 Grand Avenue Pkwy
- City
- Austin
- State
- TX
- ZIP
- 78728
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK180278
Owner / Operator
- Firm Name
- ORIGEN BIOMEDICAL, INC.
- Operator Number
- 9004483
- Address
- 7000 Burleson Rd., Bldg D, --
- City
- Austin
- State
- TX
- Postal Code
- 78744
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2011-04-25 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2022-03-11 |
| Tube, Tissue Culture | KJG | Class 1 | Pathology | No | 2016-09-21 |
| Device, Heat-Sealing | KSD | Class 1 | Hematology | No | 2012-06-25 |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | Class 2 | Hematology | No | 2018-12-12 |
| Container, Frozen Donor Tissue Storage | LPZ | Class U | Unknown | No | 2007-11-06 |
Proprietary Names
PermaLife® Cell Culture Bag, Evolve Cell Culture Bag
TissueVault Cell & Tissue Freezing Bag, O-Wrap Bag
Accessories
Tube Sealer
CryoStore Multi-Chamber Bag
PermaLife® Cell Culture Bag
CryoStore Freezing Bag
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device