FDA UDI
In Commercial Distribution
🇺🇸 United States
HbA1c CALIBRATOR SET
DI: 03701700828709
·
Model: HBAC-0043
·
VITALSCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HbA1c CALIBRATOR SET
- Primary DI
- 03701700828709
- Version / Model
- HBAC-0043
- Company Name
- VITALSCIENTIFIC
- Labeler DUNS
- 267732378
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-31
- Public Version
- 1
- Public Version Date
- 2025-04-08
- Public Version Status
- New
- Public Device Record Key
- 3a90f58d-49ed-4559-94d0-95c1c44c76da
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
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 | 03701700828709 | GS1 |