FDA UDI
In Commercial Distribution
🇺🇸 United States
Procise IFX
DI: 08100322953854
·
Model: 5385
·
Chembio Diagnostic Systems Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Procise IFX
- Primary DI
- 08100322953854
- Version / Model
- 5385
- Company Name
- Chembio Diagnostic Systems Inc.
- Labeler DUNS
- 160348470
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-16
- Public Version
- 2
- Public Version Date
- 2025-07-11
- Public Version Status
- Update
- Public Device Record Key
- 579dc0c1-fc4f-4505-b93d-1e8d0450f35b
Device Description
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QXT | Infliximab Test System | Clinical Toxicology | 862.3115 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67291 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08100322953854 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius