| Primary Device ID | 00812101031216 |
| NIH Device Record Key | 2ce99509-f539-4897-9bc1-89d2eff1ca14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARK™ Methotrexate II Control |
| Version Model Number | 5071-0003-02 |
| Catalog Number | 5071-0003-02 |
| 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 | 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 | 00812101031216 [Primary] |
| LAO | Enzyme Immunoassay, Methotrexate |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-01 |
| Device Publish Date | 2024-10-24 |
| 00812101031216 | ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II |
| 00812101031209 | ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II |
| 00812101031193 | ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II |