Data / Medical devices / United States / Bion Enterprises, Ltd.
Bion Enterprises, Ltd.: FDA-registered device maker in Des Plaines, IL, United States, 12 510(k) clearances
Bion Enterprises, Ltd. is registered with the FDA (registration 1419968) in Des Plaines, IL, United States. It lists 22 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 5, 1990. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1419968
- Address
- 455 State St Ste 100, Des Plaines, IL, United States, 60016
- Owner or operator
- BION ENTERPRISES, LTD. (1419968)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 25, 1992
- Registered through
- 2026
- Brand names listed
- ADENOVIRUS IFA SLIDES, Antibody Test Systems, Antigen Substrate Slide, B ANTIGEN SUBSTRATE SLIDES, BION Antinuclear Antibody (ANA), BION Borrelia burgdorferi, BION COXSACKIEVIRUS A, BION Chlamydia IFA Substrate Slides and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antibody Igm, If, Epstein-Barr Virus | LJN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antigen, Cf (Including Cf Control), Cytomegalovirus | GQH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antigen, Cf, (Including Cf Control), Varicella-Zoster | GQW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antisera, Cf, Herpesvirus Hominis 1,2 | GQO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antisera, Fluorescent, Adenovirus 1-33 | GNY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Antisera, Fluorescent, Chlamydia Spp. | LKI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antisera, Hai, Influenza Virus A, B, C | GNS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 | GNN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Antisera, Neutralization, Echovirus 1-34 | GNI | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Antiserum, Fluorescent, Epstein-Barr Virus | JRY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antiserum, Fluorescent, Mumps Virus | GRA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Antiserum, Fluorescent, Rubeola | GRE | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Antiserum, Hai, Rubeola | GRG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dna-Reagents, Mycoplasma Spp. | LQG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mounting Media | LEB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ph Buffer | JCC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Quality Control Slides | LJG | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Respiratory Syncytial Virus, Antigen, Antibody, Ifa | LKT | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Antigen, Nuclear, Epstein-Barr Virus | LLM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 1990 | K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | LSR | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 24, 1989 | K894622 | VARICELLA ZOSTER VIRUS | GQW | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 16, 1989 | K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | LLM | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 16, 1989 | K894624 | MUMPS VIRUS | GRA | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| October 16, 1989 | K894623 | RESPIRATORY SYNCYTIAL VIRUS | LKT | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| August 31, 1989 | K891785 | BION EBV-G (VCA) TEST SYSTEM | JRY | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| August 15, 1989 | K894625 | CHLAMYDIA (LGV-1) | LKI | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| July 14, 1989 | K893240 | BION EBV-M (VCA) TEST SYSTEM | LJN | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| February 17, 1989 | K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | LJG | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| June 7, 1988 | K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | GQO | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| June 3, 1988 | K880679 | BION CMV-G TEST SYSTEM | GQH | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
| August 17, 1987 | K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | DHN | Substantially Equivalent | Bion Ent., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 23, 2013 | 64164 | Class III | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Antiserum, Fluorescent, Epstein-Barr Virus
- All makers of Mounting Media
- All makers of Antisera, Hai, Influenza Virus A, B, C
- All makers of Ph Buffer
Updated June 5, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.