| Primary Device ID | M74902140B1 |
| NIH Device Record Key | 96491aa8-bea2-4da1-b12b-507524f34839 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEp-2 Fluorescent w/cs ANA Test System |
| Version Model Number | 2140B |
| Catalog Number | 2140B |
| Company DUNS | 038271904 |
| Company Name | IMMUNO CONCEPTS INC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |