Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419968

FEI Number

1419968

Entity Name

BION ENTERPRISES, LTD.

City/State/Country

DES PLAINES, IL, US

Establishment Address

455 State St Ste 100, DES PLAINES, IL 60016, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

BION ENTERPRISES, LTD. (Owner Number: 1419968)

Owner / Operator Contact Address

455 STATE STREET,, SUITE 100, Des Plaines, IL 60016, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K894624

PMA Number

N/A

All Registered Proprietary Names

Substrate Slide BION Respiratory Syncytia IFA BION MYCOPLASMA PNEUMONIA BION Chlamydia IFA Substrate Slides BION IFA DILUENT Antibody Test Systems BION Herpes Simplex Type 1 or BION Herpes Simplex Type 2 MUMPS-G IFA TEST SYSTEM Antigen Substrate Slide BION Borrelia burgdorferi MEASLES-G IFA TEST SYSTEM Control Slides BION Direct Identification VIRAL DIRECT IDENTIFICATION CELL CULTURE SUBSTRATE INFECT BION DIRECT IDENTIFI CELL CULTURE SUBSTRATE FOR EPS VIRAL DIRECT IDENTIFICATION CO BORRELIA BURGDORFERI SU EBV IgG (VCA) Test System BION ECHOVIRUS ANTI BION Cytomegalovirus, IgG Test System ADENOVIRUS IFA SLIDES BION Antinuclear Antibody (ANA) Test System BION Varicella-Zoster IFA Substrate Slides Substrate Slides BION Mumps Virus IFA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Microbiology	Class 1	866.3480	2007-11-14
LQG	Dna-Reagents, Mycoplasma Spp.	Microbiology	Class 1	866.3375	1999-05-24
LKI	Antisera, Fluorescent, Chlamydia Spp.	Microbiology	Class 1	866.3120	2007-11-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1999-05-24
GQO	Antisera, Cf, Herpesvirus Hominis 1,2	Microbiology	Class 2	866.3305	2007-11-14
GRA	Antiserum, Fluorescent, Mumps Virus	Microbiology	Class 1	866.3380	2005-04-04
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2007-11-14
GRE	Antiserum, Fluorescent, Rubeola	Microbiology	Class 1	866.3520	2005-04-04
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2007-11-14
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	1992-06-25
JRY	Antiserum, Fluorescent, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-11-14
GNI	Antisera, Neutralization, Echovirus 1-34	Microbiology	Class 1	866.3205	1999-05-24
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus	Microbiology	Class 2	866.3175	2007-11-14
GNY	Antisera, Fluorescent, Adenovirus 1-33	Microbiology	Class 1	866.3020	2005-04-04
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-11-14
GQW	Antigen, Cf, (Including Cf Control), Varicella-Zoster	Microbiology	Class 2	866.3900	2007-11-14
GRA	Antiserum, Fluorescent, Mumps Virus	Microbiology	Class 1	866.3380	2007-11-14

Official Correspondent

NADINE SHABAT

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BION ENTERPRISES, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852782	Clinical Sciences, Inc.	HSVI - IGG ELISA-KIT	1986-01-21
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1419968. Last updated year: 2026. Please use registration number 1419968 when referencing this establishment in official correspondence.