| Primary Device ID | 00850229007164 |
| NIH Device Record Key | c04e776a-9dde-4ce7-bd7d-a8462d2e7c0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DriDye 492 |
| Version Model Number | 492 |
| Catalog Number | E002-492 |
| Company DUNS | 071065130 |
| Company Name | AWARENESS TECHNOLOGY, INCORPORATED |
| 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 | false |
| 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 |
|---|---|
| GS1 | 00850229007164 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-06-30 |
| 00850229007010 - StatFax | 2023-06-13 |
| 00850229007027 - StatFax | 2023-06-13 |
| 00850229007034 - StatFax | 2023-06-13 |
| 00850229007041 - StatFax | 2023-06-13 |
| 00850229007072 - StatFax | 2023-06-13 Digital Dry Bath |
| 00850229007089 - StatFax | 2023-06-13 Digital Dry Bath |
| 00850229007102 - StatFax | 2023-06-13 |
| 00850229007126 - LumiStat | 2023-06-13 |