| Primary Device ID | 00858724003179 |
| NIH Device Record Key | 8c11259b-6cf0-4357-8890-af2f5531a860 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARK™ Methotrexate Control |
| Version Model Number | 5026-0003-00 |
| Catalog Number | 5026-0003-00 |
| Company DUNS | 164880598 |
| Company Name | ARK DIAGNOSTICS 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 | true |
| 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 |
| Phone | 5102706270 |
| customersupport@ark-tdm.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858724003179 [Primary] |
| LAS | Drug Specific Control Materials |
| 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 | 2016-09-24 |
| 00858724003391 | The ARK™ Methotrexate Control consists of a three-level set used for quality control of the as |
| 00858724003193 | The ARK™ Methotrexate Control consists of a three-level set used for quality control of the as |
| 00858724003186 | The ARK™ Methotrexate Control consists of a three-level set used for quality control of the as |
| 00858724003179 | The ARK™ Methotrexate Control consists of a six-level set used for quality control of the assa |