ARK™ Lacosamide Assay
- Primary DI
- 00858724003339
- Brand
- ARK™ Lacosamide Assay
- Company
- ARK DIAGNOSTICS INC
- Model
- 5033-0001-00
- Catalog number
- 5033-0001-00
- Device description
- The ARK™ Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
- Published
- 2018-02-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00858724003339 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00858724003339 | 00858724003339 | 858724003339 | 0858724003339 |
GMDN Terms
| Term | Definition |
|---|
| Multiple anticonvulsant therapeutic drug monitoring IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 164880598
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00812101030240 | ARK™ UR-144/JWH-018 Assay | 5054-0001-00 | 5054-0001-00 | 2019-07-23 |
| 00812101030257 | ARK™ UR-144/JWH-018 Assay | 5054-0001-01 | 5054-0001-01 | 2019-07-23 |
| 00812101030264 | ARK™ UR-144/JWH-018 Negative Calibrator | 5054-0002-01 | 5054-0002-01 | 2019-07-23 |
| 00812101030271 | ARK™ UR-144/JWH-018 Cutoff Calibrator | 5054-0002-02 | 5054-0002-02 | 2019-07-23 |
| 00812101030288 | ARK™ UR-144/JWH-018 Control | 5054-0003-00 | 5054-0003-00 | 2019-07-23 |
| 00812101030349 | ARK™ AB-PINACA Assay | 5055-0001-00 | 5055-0001-00 | 2019-07-23 |
| 00812101030356 | ARK™ AB-PINACA Assay | 5055-0001-01 | 5055-0001-01 | 2019-07-23 |
| 00812101030363 | ARK™ AB-PINACA Negative Calibrator | 5055-0002-01 | 5055-0002-01 | 2019-07-23 |
| 00812101030370 | ARK™ AB-PINACA Cutoff Calibrator | 5055-0002-02 | 5055-0002-02 | 2019-07-23 |
| 00812101030387 | ARK™ AB-PINACA Control | 5055-0003-00 | 5055-0003-00 | 2019-07-23 |
| 00812101031599 | ARK™ Ketamine II Assay | 5083-0001-00 | 5083-0001-00 | 2025-12-27 |
| 00812101031605 | ARK™ Ketamine II Assay | 5083-0001-01 | 5083-0001-00 | 2025-12-27 |
| 00812101031612 | ARK™ Ketamine II Assay | 5083-0001-02 | 5083-0001-02 | 2025-12-27 |
| 00812101031629 | ARK™ Ketamine II Calibrator | 5083-0002-00 | 5083-0002-00 | 2025-12-27 |
| 00812101031636 | ARK™ Ketamine II Calibrator (Negative) | 5083-0002-01 | 5083-0002-01 | 2025-12-27 |
| 00812101031643 | ARK™ Ketamine II Calibrator (50 ng/mL Cutoff) | 5083-0002-02 | 5083-0002-02 | 2025-12-27 |
| 00812101031650 | ARK™ Ketamine II Calibrator (100 ng/mL Cutoff) | 5083-0002-03 | 5083-0002-03 | 2025-12-27 |
| 00812101031667 | ARK™ Ketamine II Control (25/75) | 5083-0003-00 | 5083-0003-00 | 2025-12-27 |
| 00812101031674 | ARK™ Ketamine II Control (75/125) | 5083-0003-01 | 5083-0003-01 | 2025-12-27 |
| 00812101031995 | ARK™ Ketamine II Assay | 5083-0001-03 | 5083-0001-03 | 2025-12-27 |
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