| Primary Device ID | 07613336149201 |
| NIH Device Record Key | 4baf60a2-6a65-4553-97f4-2533ad6f8191 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VENTANA CLDN18 (43-14A) RxDx Assay |
| Version Model Number | 08287066001 |
| Catalog Number | 08287066001 |
| 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 | 07613336149201 [Primary] |
| QJZ | Extracorporeal system for long-term respiratory / cardiopulmonary failure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| 07613336149201 - VENTANA CLDN18 (43-14A) RxDx Assay | 2024-12-19 |
| 07613336149201 - VENTANA CLDN18 (43-14A) RxDx Assay | 2024-12-19 |
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