| Primary Device ID | B110AN10120 |
| NIH Device Record Key | 286489a9-9255-4df8-a581-e37ad00c4bf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System |
| Version Model Number | AN-1012 |
| Catalog Number | AN-1012 |
| 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 | 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B110AN10120 [Primary] |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-04 |
| Device Publish Date | 2016-09-12 |
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| B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System | 2020-03-04 |
| B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System | 2020-03-04 |