This page includes the latest FDA filings for Bion Enterprises L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Bion Enterprises L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 1419968 |
| FEI Number | 1419968 |
| Name | BION ENTERPRISES, LTD. |
| Owner & Operator | BION ENTERPRISES, LTD. |
| Contact Address | 455 STATE STREET, SUITE 100 Des Plaines IL 60016 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 455 State St Ste 100 DES PLAINES, IL 60016 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| Bion Enterprises, Ltd. | BP 180 ELISA TEST RG-M7612-D | 2020-04-09 |
| Bion Enterprises, Ltd. | Borrelia IgM Control BBM-6130 | 2020-04-09 |
| Bion Enterprises, Ltd. | ANA Scl-70 Control SCL-1046 | 2020-03-04 |
| Bion Enterprises, Ltd. | RSV Negative Control RSN-9010 | 2020-03-04 |
| Bion Enterprises, Ltd. | RSV IgG Control RSG-9020 | 2020-03-04 |
| Bion Enterprises, Ltd. | Respiratory Syncytial Virus Antigen Substrate, 12 wells, For IFA Test System RS-9012 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA RNP Control RNP-1044 | 2020-03-04 |
| Bion Enterprises, Ltd. | BP 230 ELISA TEST RG-M7613-D | 2020-03-04 |
| Bion Enterprises, Ltd. | DSG 1 & DSG 3 ELISA TEST RG-M7593-D | 2020-03-04 |
| Bion Enterprises, Ltd. | Varicella Zoster Virus Antigen Control Slide, 2 wells QVZ-7002 | 2020-03-04 |
| Bion Enterprises, Ltd. | Respiratory Syncytial Virus Antigen Control Slide, 2 wells QRS-9002 | 2020-03-04 |
| Bion Enterprises, Ltd. | Respiratory Virus Panel Antigen Control Slide, 14 wells QRP-6314 | 2020-03-04 |
| Bion Enterprises, Ltd. | Parainfluenza Virus Antigen Control Slide, 6 wells QP-8506 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps Antigen Control Slide, 2 wells QMU-8002 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles (Rubeola) Antigen Control Slide, 2 wells QME-6002 | 2020-03-04 |
| Bion Enterprises, Ltd. | Herpes Simplex Virus Antigen Control Slide, 4 wells QHS-3504 | 2020-03-04 |
| Bion Enterprises, Ltd. | Enterovirus Panel Antigen Control Slide, 4 wells QEP-6604 | 2020-03-04 |
| Bion Enterprises, Ltd. | Cytomegalovirus Antigen Control Slide, 2 wells QCM-2002 | 2020-03-04 |
| Bion Enterprises, Ltd. | Chlamydia Antigen Contol Slide (Elem. Bodies), 2 wells QCHE-4502 | 2020-03-04 |
| Bion Enterprises, Ltd. | Chlamydia Antigen Control Slide, 2 wells QCH-4102 | 2020-03-04 |
| Bion Enterprises, Ltd. | Adenovirus Antigen Control Slide, 2 wells QAD-3102 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza A & B Virus Antigen Control Slide, 4 wells QAB-1504 | 2020-03-04 |
| Bion Enterprises, Ltd. | Parainfluenza 1, 2, & 3 Negative Control PN-8510 | 2020-03-04 |
| Bion Enterprises, Ltd. | Parainfluenza 1, 2, & 3 IgG Control PG-8520 | 2020-03-04 |
| Bion Enterprises, Ltd. | Parainfluenza 3 Virus Antigen Substrate, 12 wells, For IFA Test System P3-9112 | 2020-03-04 |
| Bion Enterprises, Ltd. | Parainfluenza 2 Virus Antigen Substrate, 12 wells, For IFA Test System P2-8112 | 2020-03-04 |
| Bion Enterprises, Ltd. | Parainfluenza 1 Virus Antigen Substrate, 12 wells, For IFA Test System P1-7112 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA Nucleolar Control NUC-1042 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBNA Positive Control NA-5140 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System NA-5112 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps Negative Control MUN-8010 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps IgM Control MUM-8030 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps IgG Control MUG-8020 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps IgG Test System, 60 Tests MUG-60 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps IgG Test System, 120 Tests MUG-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps Virus Antigen Substrate, 12 wells, For IFA Test System MU-8012 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mumps Virus Antigen Substrate, 6 wells, For IFA Test System MU-8006 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mycoplasma pneumoniae Negative Control MPN-1210 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mycoplasma pneumoniae IgM Control MPM-1230 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mycoplasma pneumoniae IgG Control MPG-1220 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mycoplasma pneumoniae Antigen Substrate, 12 wells, For IFA Test System MP-1212 | 2020-03-04 |
| Bion Enterprises, Ltd. | Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System MP-1206 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles Negative Control MEN-6010 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles IgM Control MEM-6030 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles IgM Test System, 120 Tests MEM-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles IgG Control MEG-6020 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles IgG Test System, 120 Tests MEG-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test System ME-6012 | 2020-03-04 |
| Bion Enterprises, Ltd. | Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test System ME-6006 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza B Negative Control IBN-2110 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza B IgG Control IBG-2120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System IB-2112 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza A Negative Control IAN-1110 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza A IgG Control IAG-1120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Influenza A Virus Antigen Substrate, 12 wells, For IFA Test System IA-1112 | 2020-03-04 |
| Bion Enterprises, Ltd. | Herpes Simplex Negative Control HSN-3510 | 2020-03-04 |
| Bion Enterprises, Ltd. | Herpes Simplex IgM Control HSM-3530 | 2020-03-04 |
| Bion Enterprises, Ltd. | Herpes Simplex IgG Control HSG-3520 | 2020-03-04 |
| Bion Enterprises, Ltd. | HSV-2 IgG Test System, 120 Tests HS2G-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System HS2-4012 | 2020-03-04 |
| Bion Enterprises, Ltd. | HSV-1 IgG Test System, 120 Tests HS1G-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System HS1-3012 | 2020-03-04 |
| Bion Enterprises, Ltd. | Echovirus Negative Control ECN-4410 | 2020-03-04 |
| Bion Enterprises, Ltd. | Echovirus IgG Control ECG-4420 | 2020-03-04 |
| Bion Enterprises, Ltd. | Echovirus Screen Virus Antigen Substrate, 12 wells, For IFA Test System EC-4412 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBV Negative Control EBN-5010 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBV IgM Control EBM-5030 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBV-VCA IgM Test System, 120 Tests EBM-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBV IgG Control EBG-5020 | 2020-03-04 |
| Bion Enterprises, Ltd. | EBV-VCA IgG Test System, 120 Tests EBG-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System EB-5012 | 2020-03-04 |
| Bion Enterprises, Ltd. | CMV Negative Control CMN-2010 | 2020-03-04 |
| Bion Enterprises, Ltd. | CMV IgM Control CMM-2030 | 2020-03-04 |
| Bion Enterprises, Ltd. | CMV IgG Control CMG-2020 | 2020-03-04 |
| Bion Enterprises, Ltd. | CMV IgG Test System, 120 Tests CMG-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System CM-2012 | 2020-03-04 |
| Bion Enterprises, Ltd. | Chlamydia Negative Control CHN-4110 | 2020-03-04 |
| Bion Enterprises, Ltd. | Chlamydia IgG Control CHM-4130 | 2020-03-04 |
| Bion Enterprises, Ltd. | Chlamydia IgG Control CHG-4120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Chlamydia Antigen Substrate, 12 wells, For IFA Test System CH-4112 | 2020-03-04 |
| Bion Enterprises, Ltd. | Coxsackie B1-B6 Negative Control CBN-3310 | 2020-03-04 |
| Bion Enterprises, Ltd. | Coxsackie B1-B6 IgG Control CBG-3320 | 2020-03-04 |
| Bion Enterprises, Ltd. | Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System CB-3312 | 2020-03-04 |
| Bion Enterprises, Ltd. | Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System CB-3306 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA Calibrator CAL-1090 | 2020-03-04 |
| Bion Enterprises, Ltd. | Borrelia Negative Control BBN-6110 | 2020-03-04 |
| Bion Enterprises, Ltd. | Borrelia IgG Control BBG-6120 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA Homogeneous Control ANP-1040 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA Negative Control ANN-1010 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA (HEp-2) Test System, 60 Tests ANK-60 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA (HEp-2) Test System, 120 Tests ANK-120 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA (HEp-2) Test System, 300 Tests AND-300 I | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA (HEp-2) Test System, 1800 Tests AND-1800 I | 2020-03-04 |
| Bion Enterprises, Ltd. | Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System AN-1016 | 2020-03-04 |
| Bion Enterprises, Ltd. | Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System AN-1012 | 2020-03-04 |
| Bion Enterprises, Ltd. | Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System AN-1006 | 2020-03-04 |
| Bion Enterprises, Ltd. | Adenovirus Negative Control ADN-3110 | 2020-03-04 |
| Bion Enterprises, Ltd. | Adenovirus IgG Control ADG-3120 | 2020-03-04 |
| Bion Enterprises, Ltd. | Adenovirus Antigen Substrate, 12 wells, For IFA Test System AD-3112 | 2020-03-04 |
| Bion Enterprises, Ltd. | ANA ACA Control ACA-1043 | 2020-03-04 |
BION ENTERPRISES, LTD. | MBL Bion HEP-ANA Test System | 2011-05-02 |
BION ENTERPRISES, LTD. | BION Borrelia burgdorferi | 2007-11-14 |
BION ENTERPRISES, LTD. | Antigen Substrate Slide | 2007-11-14 |
BION ENTERPRISES, LTD. | Substrate Slide | 2007-11-14 |
BION ENTERPRISES, LTD. | BION EBV Nuclear Antigen IFA | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Chlamydia IFA Substrate Slides | 2007-11-14 |
BION ENTERPRISES, LTD. | Substrate Slides | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Mumps Virus IFA | 2007-11-14 |
BION ENTERPRISES, LTD. | Substrate Slide | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Respiratory Syncytia IFA | 2007-11-14 |
BION ENTERPRISES, LTD. | Substrate Slides | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Varicella-Zoster IFA | 2007-11-14 |
BION ENTERPRISES, LTD. | BION EBV IgM (VCA) Test System | 2007-11-14 |
BION ENTERPRISES, LTD. | EBV IgG (VCA) Test System | 2007-11-14 |
BION ENTERPRISES, LTD. | Control Slides | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Direct Identification | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Herpes Simplex Type 2 | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Herpes Simplex Type 1 or | 2007-11-14 |
BION ENTERPRISES, LTD. | Antibody Test Systems | 2007-11-14 |
BION ENTERPRISES, LTD. | Test System | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Cytomegalovirus, IgG | 2007-11-14 |
BION ENTERPRISES, LTD. | Test System | 2007-11-14 |
BION ENTERPRISES, LTD. | BION Antinuclear Antibody (ANA) | 2007-11-14 |
BION ENTERPRISES, LTD. | BION IFA MOUNTING MEDIA | 2005-04-04 |
BION ENTERPRISES, LTD. | BION PBS IFA BUFFER | 2005-04-04 |
BION ENTERPRISES, LTD. | MEASLES-M IFA TEST SYSTEM | 2005-04-04 |
BION ENTERPRISES, LTD. | MEASLES-G IFA TEST SYSTEM | 2005-04-04 |
BION ENTERPRISES, LTD. | MUMPS-G IFA TEST SYSTEM | 2005-04-04 |
BION ENTERPRISES, LTD. | PARAINFLUENZA 1 | 2005-04-04 |
BION ENTERPRISES, LTD. | 2 OR 3 IFA SLIDES | 2005-04-04 |
BION ENTERPRISES, LTD. | ADENOVIRUS IFA SLIDES | 2005-04-04 |
BION ENTERPRISES, LTD. | INFLUENZA A OR B IFA SLIDES | 2005-04-04 |
BION ENTERPRISES, LTD. | BION IFA DILUENT | 1999-05-24 |
BION ENTERPRISES, LTD. | BION MYCOPLASMA PNEUMONIA | 1999-05-24 |
BION ENTERPRISES, LTD. | BION PARAINFLUENZA TYPE 4 | 1999-05-24 |
BION ENTERPRISES, LTD. | BION COXSACKIEVIRUS A | 1999-05-24 |
BION ENTERPRISES, LTD. | B ANTIGEN SUBSTRATE SLIDES | 1999-05-24 |
BION ENTERPRISES, LTD. | BION ECHOVIRUS ANTI | 1999-05-24 |
BION ENTERPRISES, LTD. | VIRAL DIRECT IDENTIFICATION | 1992-06-25 |
BION ENTERPRISES, LTD. | VIRAL DIRECT IDENTIFICATION CO | 1992-06-25 |
BION ENTERPRISES, LTD. | CELL CULTURE SUBSTRATE INFECT | 1992-06-25 |
BION ENTERPRISES, LTD. | CELL CULTURE SUBSTRATE FOR EPS | 1992-06-25 |
BION ENTERPRISES, LTD. | BORRELIA BURGDORFERI SU | 1992-06-25 |
BION ENTERPRISES, LTD. | BION DIRECT IDENTIFI | 1992-06-25 |
| NCAGE Code | 071B9 | BION ENTERPRISES LTD. |
| CAGE Code | 071B9 | BION ENTERPRISES, LTD. |