| Primary Device ID | 10888234102229 |
| NIH Device Record Key | 31a115cc-62d2-410b-85f7-3c78f0bd7c08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioArray Assay Imaging System TM (AIS) 400D |
| Version Model Number | 790-20016 |
| Catalog Number | 790-20016 |
| Company DUNS | 949103725 |
| Company Name | BIOARRAY SOLUTIONS 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid exposure to direct sunlight |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Temperature of 15 degrees Celsius to 26.7 degrees Celcius when in use |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234102229 [Primary] |
| NSU | Instrumentation For Clinical Multiplex Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-06 |
| 10888234102236 | 790-20016-RF |
| 10888234102229 | 790-20016 |