FDA UDI
In Commercial Distribution
🇺🇸 United States
FRUCTOSAMINE (FRUC)
DI: 05055273208733
·
Model: FR4030
·
RANDOX LABORATORIES LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FRUCTOSAMINE (FRUC)
- Primary DI
- 05055273208733
- Version / Model
- FR4030
- Catalog Number
- FR4030
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-03
- Public Version
- 3
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- ec28f91a-962c-4c3e-8f4f-4f9276996b98
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53274 | Fructosamine IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the glycated serum protein fructosamine in a clinical specimen, using a spectrophotometry method. It is typically used to aid in monitoring of average glucose levels and glycaemic control in diabetic patients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273208733 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110188 | 000 |