FDA UDI
In Commercial Distribution
🇺🇸 United States
ConcizuTrace™ ELISA
DI: 05055273218985
·
Model: CZM10591
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ConcizuTrace™ ELISA
- Primary DI
- 05055273218985
- Version / Model
- CZM10591
- Catalog Number
- CZM10591
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-30
- Public Version
- 1
- Public Version Date
- 2025-06-09
- Public Version Status
- New
- Public Device Record Key
- 8d9de463-c8c6-4980-9045-3817769c2491
Device Description
The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.
Device Characteristics
- Single Use
- No
- 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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SES | Non-Factor Replacement Product Test System | Hematology | 864.7298 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66368 | Concizumab 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 the therapeutic antibody concizumab, an anti-tissue factor pathway inhibitor (TFPI), in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273218985 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN240035 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius