ARK™ Efavirenz Calibrator
- Primary DI
- 00858724003360
- Brand
- ARK™ Efavirenz Calibrator
- Company
- ARK DIAGNOSTICS INC
- Model
- 5017-0002-00
- Catalog number
- 5017-0002-00
- Device description
- ARK™ Efavirenz Calibrator is intended for use in calibration of the ARK™ Efavirenz Assay.
- Published
- 2016-09-28
- 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 |
|---|
| 00858724003360 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00858724003360 | 00858724003360 | 858724003360 | 0858724003360 |
GMDN Terms
| Term | Definition |
|---|
| Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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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