| Primary Device ID | 00816870022543 |
| NIH Device Record Key | d2e1ef51-1437-46af-b31a-0537a0e7f2fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 Wells |
| Version Model Number | 8575-300 |
| Catalog Number | 8575-300B |
| Company DUNS | 083155515 |
| Company Name | MONOBIND, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |