| Primary Device ID | M7490825011 |
| NIH Device Record Key | 2654ad0b-53de-4199-8f1f-4d7a9e44a299 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluorescent nDNA Test System |
| Version Model Number | 8250.1 |
| Catalog Number | 8250.1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7490825011 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2016-09-24 |
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