| Primary Device ID | 04015630970063 |
| NIH Device Record Key | 8e636dd7-36a3-4c8f-8377-98c251036652 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONFIRM anti-ALK1 (ALK01) Primary Antibody |
| Version Model Number | 05278147001 |
| Catalog Number | 05278147001 |
| 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 | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630970063 [Primary] |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 07613336149201 - VENTANA CLDN18 (43-14A) RxDx Assay | 2024-12-19 |
| 07613336223512 - anti-p40 (SP225) Rabbit Monoclonal Primary Antibody | 2024-05-29 |
| 07613336221099 - VENTANA FGFR2b (FPR2-D) Mouse Monoclonal Antibody | 2024-02-07 |
| 07613336219898 - anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody | 2023-07-07 |
| 04015630967087 - CONFIRM anti-S100 (Polyclonal) Primary Antibody | 2022-12-15 |
| 04015630970063 - CONFIRM anti-ALK1 (ALK01) Primary Antibody | 2022-12-15 |
| 04015630970063 - CONFIRM anti-ALK1 (ALK01) Primary Antibody | 2022-12-15 |
| 04015630970445 - CINtec® p16 Histology | 2022-12-15 |
| 04015630971015 - Anti-p53 (Bp53-11) Primary Antibody | 2022-12-15 |