| Primary Device ID | 00812101031469 |
| NIH Device Record Key | 4b50999b-4cc6-4f26-85dd-331a5db3c33a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARK Levetiracetam II Assay |
| Version Model Number | 5070-0001-01 |
| Catalog Number | 5070-0001-01 |
| 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 |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com | |
| Phone | 5102706270 |
| customersupport@ark-tdm.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812101031469 [Primary] |
| ORI | Levetiracetam Assay |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-04 |
| Device Publish Date | 2024-10-25 |
| 00812101031001 - DRI Tramadol Assay - 500 mL | 2024-11-22 Tramadol Assay - 500 mL Thermo |
| 00812101031018 - DRI Tramadol Assay - 115mL | 2024-11-22 Tramadol Assay - 115 mL Thermo |
| 00812101031025 - DRI Tramadol Negative Calibrator Kit | 2024-11-22 Tramadol Negative Calibrator Kit - Thermo |
| 00812101031032 - DRI Tramadol Cutoff Calibrator Kit | 2024-11-22 Tramadol Cutoff Calibrator Kit - Thermo |
| 00812101031049 - DRI Tramadol Calibrator Kit | 2024-11-22 Tramadol Calibrator Kit - Thermo |
| 00812101031056 - DRI Tramadol Control Kit | 2024-11-22 Tramadol Control Kit - Thermo |
| 00812101031469 - ARK Levetiracetam II Assay | 2024-11-04The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. |
| 00812101031469 - ARK Levetiracetam II Assay | 2024-11-04 The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam |
| 00812101030646 - ARK™ Levetiracetam II Assay | 2024-11-01 The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam |