ARK™ Ethyl Glucuronide Assay (115mL)
- Primary DI
- 00858724003476
- Brand
- ARK™ Ethyl Glucuronide Assay (115mL)
- Company
- ARK DIAGNOSTICS INC
- Model
- 5036-0001-01
- Catalog number
- 5036-0001-01
- Device description
- The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determination of ethyl glucuronide in human urine at cutoff concentrations of 500 ng/mL and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ethyl glucuronide in urine and is designated for professional use on automated clinical chemistry analyzers.
- Published
- 2017-12-25
- 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 |
|---|
| 00858724003476 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00858724003476 | 00858724003476 | 858724003476 | 0858724003476 |
GMDN Terms
| Term | Definition |
|---|
| Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen using an enzyme immunoassay (EIA) method. |
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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