| Primary Device ID | 00875197003215 |
| NIH Device Record Key | a158ec12-b3be-4bcd-ba9b-b9705d263aed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas¿ 4800 System Control Diluent Kit |
| Version Model Number | 1.0 |
| Catalog Number | 05235847190 |
| Company DUNS | 071674100 |
| Company Name | Roche Molecular 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 | true |
| 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 | 00875197003215 [Primary] |
| LSL | DNA-REAGENTS, NEISSERIA |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-03-31 |
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