| Primary Device ID | B110BBM61300 |
| NIH Device Record Key | 52631817-88b3-43aa-a430-7cb9f2f0fbcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Borrelia IgM Control |
| Version Model Number | BBM-6130 |
| Catalog Number | BBM-6130 |
| Company DUNS | 024824641 |
| Company Name | Bion Enterprises, Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B110BBM61300 [Primary] |
| LSR | Reagent, Borrelia Serological Reagent |
| LSS | Device, Electrical Nerve Repair, Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-04-09 |
| Device Publish Date | 2016-09-12 |
| B110BBM61300 - Borrelia IgM Control | 2020-04-09 |
| B110BBM61300 - Borrelia IgM Control | 2020-04-09 |
| B110RGM7612D0 - BP 180 ELISA TEST | 2020-04-09 |
| B110ACA10430 - ANA ACA Control | 2020-03-04 |
| B110AD31120 - Adenovirus Antigen Substrate, 12 wells, For IFA Test System | 2020-03-04 |
| B110ADG31200 - Adenovirus IgG Control | 2020-03-04 |
| B110ADN31100 - Adenovirus Negative Control | 2020-03-04 |
| B110AN10060 - Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System | 2020-03-04 |
| B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System | 2020-03-04 |