| Primary Device ID | 00365702126107 |
| NIH Device Record Key | e9702845-c1c4-42bc-9429-91453e1dfb66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoaguChek XS Professional Use Care Kit |
| Version Model Number | 4837975001 |
| Catalog Number | 4837975001 |
| Company DUNS | 315028860 |
| Company Name | Roche Diagnostics GmbH |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 1 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00365702126107 [Primary] |
| GJS | TEST, TIME, PROTHROMBIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
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| 07613336227770 - Potassium electrode | 2025-03-13 |
| 07613336227787 - Chloride electrode | 2025-03-13 |
| 07613336227794 - Reference electrode | 2025-03-13 |
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| 07613336228500 - Elecsys HIV Duo | 2025-02-27 |
| 07613336183212 - PreciControl HIV Gen II | 2025-02-27 |