FDA UDI
In Commercial Distribution
🇺🇸 United States
FRUC CAL
DI: 05055273203110
·
Model: FR2993
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FRUC CAL
- Primary DI
- 05055273203110
- Version / Model
- FR2993
- Catalog Number
- FR2993
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 91d2ee16-167d-4327-b181-fb712f16e20b
Device Description
This product is intended for in vitro diagnostic use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53275 | Fructosamine IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273203110 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023763 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Once reconstituted the calibrator is stable for 28 days at +2oC to +8oC, and 1 month at –20oC when frozen once.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius