FDA UDI
In Commercial Distribution
🇺🇸 United States
HbA1C CAL
DI: 05055273203530
·
Model: HA3444
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HbA1C CAL
- Primary DI
- 05055273203530
- Version / Model
- HA3444
- Catalog Number
- HA3444
- 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
- fdaa3836-04ff-4b66-98ab-b69691f7af50
Device Description
This product is intended for in vitro diagnostic use in the calibration of HbA1c 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 |
|---|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53315 | Glycated haemoglobin (HbA1c) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273203530 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021897 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius