Contract manufacturerBION ENTERPRISES, LTD. (Des Plaines, IL)IllinoisImmunologyMicrobiologyClass IIClass I
BION ENTERPRISES, LTD.
Contract manufacturer ยท Des Plaines, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1419968 (openFDA record; or search FDA's registration database)
- FEI number
- 1419968
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- BION ENTERPRISES, LTD. (FDA owner/operator no. 1419968)
- Registered address
- 455 State St Ste 100, Des Plaines, IL 60016
- Contract listings
- 12 device listings, 12 product codes, first listed Nov 14, 2007
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Class II | Immunology | Contract manufacturing | Nov 14, 2007 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | Class II | Microbiology | Contract manufacturing | Nov 14, 2007 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | Class II | Microbiology | Contract manufacturing | Nov 14, 2007 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | Class II | Microbiology | Contract manufacturing | Nov 14, 2007 |
| GRA | Antiserum, Fluorescent, Mumps Virus | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| LJG | Quality Control Slides | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | Class I | Microbiology | Contract manufacturing | Nov 14, 2007 |
| LSR | Reagent, Borrelia Serological Reagent | Class II | Microbiology | Contract manufacturing | Nov 14, 2007 |