| Primary Device ID | 00858724003254 |
| NIH Device Record Key | 834d7c57-537d-4fae-9945-1daf2b745a88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARK™ Methotrexate Assay |
| Version Model Number | 5026-0001-02 |
| Catalog Number | 5026-0001-02 |
| 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 | 00858724003254 [Primary] |
| LAO | Enzyme Immunoassay, Methotrexate |
| 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 |
| 00858724003254 | The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitat |
| 00858724003056 | The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative det |
| 00812101030639 | The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitat |