Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBION ENTERPRISES, LTD.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 455 State St Ste 100, DES PLAINES, IL, 60016
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1419968
- DUNS Number
- —
Catalogue (106)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ANA Calibrator | CAL-1090 | FDA UDI | Class II | Active |
| Varicella Zoster Virus Antigen Substrate, 12 wells, For IFA Test System | VZ-7012 | FDA UDI | Class II | Active |
| Echovirus IgG Control | ECG-4420 | FDA UDI | Class I | Unknown |
| Herpes Simplex IgG Control | HSG-3520 | FDA UDI | Class II | Active |
| Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test System | ME-6006 | FDA UDI | Class I | Unknown |
| Chlamydia Negative Control | CHN-4110 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 23, 2013 | Z-1477-2013 | — | terminated | Affected products have a labeled expiration date of one year too long. |
| Jan 23, 2013 | Z-1478-2013 | — | terminated | Affected products have a labeled expiration date of one year too long. |
| Jan 23, 2013 | Z-1479-2013 | — | terminated | Affected products have a labeled expiration date of one year too long. |