| Primary Device ID | 04015630972173 |
| NIH Device Record Key | c75b4e97-887e-48d6-bfd0-104fd340fef5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ultraView Universal DAB Detection Kit |
| Version Model Number | 250 tests |
| Catalog Number | 05269806001 |
| Company DUNS | 184042521 |
| Company Name | Ventana Medical Systems, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630972173 [Primary] |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-12-12 |
| Device Publish Date | 2014-09-11 |
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| 04015630972197 - PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | 2025-09-08 |
| 04015630971114 - LCS (Predilute) | 2025-07-15 |