Bion Enterprises Ltd
Des Plaines, IL, US
BION ENTERPRISES, LTD. appears in FDA device records in Des Plaines, IL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1419968 | 1419968 | BION ENTERPRISES, LTD. | 455 State St Ste 100, DES PLAINES, IL 60016 US | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LJNAntibody Igm, If, Epstein-Barr Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GNYAntisera, Fluorescent, Adenovirus 1-33
- LKIAntisera, Fluorescent, Chlamydia Spp.
- GNSAntisera, Hai, Influenza Virus A, B, C
- GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-6
- GNIAntisera, Neutralization, Echovirus 1-34
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- GRAAntiserum, Fluorescent, Mumps Virus
- GREAntiserum, Fluorescent, Rubeola
- GRGAntiserum, Hai, Rubeola
- LQGDna-Reagents, Mycoplasma Spp.
- PPMGeneral Purpose Reagent
- LEBMounting Media
- JCCPh Buffer
- LJGQuality Control Slides
- LSRReagent, Borrelia Serological Reagent
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1479-2013 | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | Affected products have a labeled expiration date of one year too long. | Class III | Terminated | |
| Z-1478-2013 | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | Affected products have a labeled expiration date of one year too long. | Class III | Terminated | |
| Z-1477-2013 | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | Affected products have a labeled expiration date of one year too long. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain