ARK™ Voriconazole II Assay
- Primary DI
- 00858724003223
- Brand
- ARK™ Voriconazole II Assay
- Company
- ARK DIAGNOSTICS INC
- Model
- 5030-0001-01
- Catalog number
- 5030-0001-01
- Device description
- The ARK™ Voriconazole II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum on automated clinical chemistry analyzers.
- Published
- 2016-09-24
- 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 |
|---|
| 00858724003223 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00858724003223 | 00858724003223 | 858724003223 | 0858724003223 |
GMDN Terms
| Term | Definition |
|---|
| Voriconazole 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 that is used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug voriconazole 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 |
|---|
| 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 |
| 00812101031001 | DRI Tramadol Assay - 500 mL | B40000350 | B40000350 | 2024-11-14 |
| 00812101031018 | DRI Tramadol Assay - 115mL | B40000351 | B40000351 | 2024-11-14 |
| 00812101031025 | DRI Tramadol Negative Calibrator Kit | B40000353 | B40000353 | 2024-11-14 |
| 00812101031032 | DRI Tramadol Cutoff Calibrator Kit | B40000352 | B40000352 | 2024-11-14 |
| 00812101031049 | DRI Tramadol Calibrator Kit | B40000366 | B40000366 | 2024-11-14 |
| 00812101031056 | DRI Tramadol Control Kit | B40000354 | B40000354 | 2024-11-14 |
| 00812101031469 | ARK Levetiracetam II Assay | 5070-0001-01 | 5070-0001-01 | 2024-10-25 |
| 00812101030646 | ARK™ Levetiracetam II Assay | 5070-0001-00 | 5070-0001-00 | 2024-10-24 |
| 00812101030653 | ARK™ Levetiracetam II Calibrator | 5070-0002-00 | 5070-0002-00 | 2024-10-24 |
| 00812101030660 | ARK™ Levetiracetam II Control | 5070-0003-00 | 5070-0003-00 | 2024-10-24 |
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