| Primary Device ID | 04015630972197 |
| NIH Device Record Key | 657e2a8a-347c-4aa6-94d8-00793e2568e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
| Version Model Number | 50 tests |
| Catalog Number | 05278368001 |
| Company DUNS | 184042521 |
| Company Name | Ventana Medical Systems, 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630972197 [Primary] |
| MVC | SYSTEM, TEST, HER-2/NEU, IHC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2014-09-11 |
| 04015630972197 - PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | 2025-09-08 |
| 04015630972197 - PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | 2025-09-08 |
| 04015630971114 - LCS (Predilute) | 2025-07-15 |
| 04015630976867 - ASSY,Reag.Disp.Card,PrepKit 18,BenchMark | 2025-07-15 |
| 04015630984299 - CINtec p16 Histology (50) CE | 2025-07-15 |
| 07613336100981 - ASSY,Reag.Disp.Card,PrepKit 13,BenchMark | 2025-07-15 |
| 07613336100998 - ASSY,Reag.Disp.Card,PrepKit 14,BenchMark | 2025-07-15 |
| 07613336101001 - ASSY,Reag.Disp.Card,PrepKit 4,BenchMark | 2025-07-15 |
| 07613336101018 - ASSY,Reag.Disp.Card,PrepKit 100,BenchMar | 2025-07-15 |