Procise ADL
- Primary DI
- 08100322954301
- Brand
- Procise ADL
- Company
- PROCISEDX Inc.
- Model
- 5430
- Device description
- The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.
- Published
- 2024-08-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| QYD | Adalimumab Assay |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QYD | Adalimumab Assay | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08100322954301 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08100322954301 | 08100322954301 | 8100322954301 |
GMDN Terms
| Term | Definition |
|---|
| TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic drug monitoring of a tumour necrosis factor-alpha (TNF-alpha) inhibitor (e.g., infliximab, adalimumab, golimumab and etanercept) in a clinical specimen, using a fluorescent immunoassay method. The assay is typically used to monitor blood levels of anti-TNF-alpha therapeutics in the treatment of autoimmune conditions such as Crohn's disease, ulcerative colitis and rheumatoid arthritis. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 117361503
- 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
- true
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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