mblintl.comANA (HEp-2) Test System, 300 Tests - AND-300 I
2016-09-12
BION ENTERPRISES, LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1419968 | 1419968 | BION ENTERPRISES, LTD. | 1 | Y | 2026-01-01 | 455 State St Ste 100 DES PLAINES IL US 60016 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B110ACA10430 | ANA ACA Control - ACA-1043 | 847-544-5044 | bion@mblintl.com |
| B110AN10060 | Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System - AN-1006 | 847-544-5044 | bion@mblintl.com |
| B110AN10120 | Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System - AN-1012 | 847-544-5044 | bion@mblintl.com |
| B110AN10160 | Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System - AN-1016 | 847-544-5044 | bion@mblintl.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 31331 | 1890319202 | K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | LSR | 1990-04-05 |
| 31331 | 1180433683 | K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | LLM | 1989-10-16 |
| 31331 | 1574934797 | K894625 | CHLAMYDIA (LGV-1) | LKI | 1989-08-15 |
| 31331 | 1875981357 | K894624 | MUMPS VIRUS | GRA | 1989-10-16 |
| 31331 | 1950275429 | K894623 | RESPIRATORY SYNCYTIAL VIRUS | LKT | 1989-10-16 |
| 31331 | 1138373074 | K894622 | VARICELLA ZOSTER VIRUS | GQW | 1989-10-24 |
| 31331 | 1683286528 | K893240 | BION EBV-M (VCA) TEST SYSTEM | LJN | 1989-07-14 |
| 31331 | 1303462728 | K891785 | BION EBV-G (VCA) TEST SYSTEM | JRY | 1989-08-31 |
| 31331 | 1897228089 | K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | LJG | 1989-02-17 |
| 31331 | 1890589838 | K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | GQO | 1988-06-07 |
| 31331 | 1041279361 | K880679 | BION CMV-G TEST SYSTEM | GQH | 1988-06-03 |
| 31331 | 1657927117 | K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | DHN | 1987-08-17 |
| 31331 | 2013469213 | K042680 | RHIGENE HEP-ANA TEST SYSTEM | DHN | 2004-11-19 |
| 31331 | 1402483346 | ||||
| 31331 | 1557236640 | ||||
| 31331 | 1082387196 | ||||
| 31331 | 1132334317 | ||||
| 31331 | 1155188493 | ||||
| 31331 | 1220430953 | ||||
| 31331 | 1342470217 | ||||
| 31331 | 1735532481 | ||||
| 31331 | 1741106718 | ||||
| 31331 | 1820381076 | ||||
| 31331 | 1907771039 | ||||
| 31331 | 1991201955 | ||||
| 31331 | 2037934279 | ||||
| 31331 | 2061759477 |
Product Codes Associated With Registrations#
GUDID#
ANA Calibrator - CAL-1090
2016-09-12
ANA ACA Control - ACA-1043
2016-09-12
Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System - AN-1006
2016-09-12
Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System - AN-1012
2016-09-12
Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System - AN-1016
2016-09-12
ANA (HEp-2) Test System, 1800 Tests - AND-1800 I
2016-09-12
ANA (HEp-2) Test System, 120 Tests - ANK-120
2016-09-12
ANA (HEp-2) Test System, 60 Tests - ANK-60
2016-09-12
ANA Negative Control - ANN-1010
2016-09-12
ANA Homogeneous Control - ANP-1040
2016-09-12
ANA Nucleolar Control - NUC-1042
2016-09-12
ANA RNP Control - RNP-1044
2016-09-12
ANA Scl-70 Control - SCL-1046
2016-09-12
ANA SSA Control - SSA-1045
2016-09-12
ANA SSB Control - SSB-1047
2016-09-12
Respiratory Virus Panel Antigen Control Slide, 14 wells - QRP-6314
2016-09-12
Chlamydia Antigen Control Slide, 2 wells - QCH-4102
2016-09-12
Mumps IgG Test System, 60 Tests - MUG-60
2016-09-12
EBNA Positive Control - NA-5140
2016-09-12
EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System - NA-5112
2016-09-12
Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System - CB-3306
2016-09-12
Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System - CB-3312
2016-09-12
Coxsackie B1-B6 IgG Control - CBG-3320
2016-09-12
Coxsackie B1-B6 Negative Control - CBN-3310
2016-09-12
Mumps Virus Antigen Substrate, 6 wells, For IFA Test System - MU-8006
2016-09-12
Parainfluenza 1 Virus Antigen Substrate, 12 wells, For IFA Test System - P1-7112
2016-09-12
Parainfluenza 2 Virus Antigen Substrate, 12 wells, For IFA Test System - P2-8112
2016-09-12
Parainfluenza 3 Virus Antigen Substrate, 12 wells, For IFA Test System - P3-9112
2016-09-12
DSG 1 & DSG 3 ELISA TEST - RG-M7593-D
2016-09-12
BP 230 ELISA TEST - RG-M7613-D
2016-09-12
Borrelia IgM Control - BBM-6130
2016-09-12
BP 180 ELISA TEST - RG-M7612-D
2016-09-12
Adenovirus Antigen Substrate, 12 wells, For IFA Test System - AD-3112
2016-09-12
Adenovirus IgG Control - ADG-3120
2016-09-12
Adenovirus Negative Control - ADN-3110
2016-09-12
Borrelia IgG Control - BBG-6120
2016-09-12
Borrelia Negative Control - BBN-6110
2016-09-12
Chlamydia Antigen Substrate, 12 wells, For IFA Test System - CH-4112
2016-09-12
Chlamydia IgG Control - CHG-4120
2016-09-12