FDA UDI
In Commercial Distribution
🇺🇸 United States
ExtendSure
DI: 09421902348112
·
Model: 107253
·
CANTERBURY SCIENTIFIC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ExtendSure
- Primary DI
- 09421902348112
- Version / Model
- 107253
- Catalog Number
- HB510Ar
- Company Name
- CANTERBURY SCIENTIFIC LIMITED
- Labeler DUNS
- 590649471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-12
- Public Version
- 1
- Public Version Date
- 2020-10-20
- Public Version Status
- New
- Public Device Record Key
- a97eb994-4c06-49b4-bb5b-24fb8129361e
Device Description
The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability. The Lyophilized Hemoglobin A1c Linearity Controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols setup within individual clinical laboratories.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52856 | Glucose/haemoglobin (Hb) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose and haemoglobin (Hb) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421902348112 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius