| Primary Device ID | B110CB33060 |
| NIH Device Record Key | 21e411b0-4e68-426a-b667-103f260ea5a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System |
| Version Model Number | CB-3306 |
| Catalog Number | CB-3306 |
| Company DUNS | 024824641 |
| Company Name | Bion Enterprises, Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com | |
| Phone | 847-544-5044 |
| bion@mblintl.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B110CB33060 [Primary] |
| GNN | Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-04 |
| Device Publish Date | 2016-09-12 |