| Primary Device ID | 04015630976867 |
| NIH Device Record Key | 790e5709-ad9e-4a56-b85a-4cb8787f97a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASSY,Reag.Disp.Card,PrepKit 18,BenchMark |
| Version Model Number | 05251516001 |
| Catalog Number | 05251516001 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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 | 04015630976867 [Primary] |
| JRC | MICRO PIPETTE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-15 |
| Device Publish Date | 2025-07-07 |
| 07613336233764 - CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody | 2025-09-12 |
| 07613336234426 - VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody | 2025-09-12 250 Tests |
| 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 |
| 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 |