FDA UDI
In Commercial Distribution
🇺🇸 United States
Fructosamine Calibrator
DI: 00817238011032
·
Model: R85321
·
CLINIQA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fructosamine Calibrator
- Primary DI
- 00817238011032
- Version / Model
- R85321
- Company Name
- CLINIQA CORPORATION
- Labeler DUNS
- 078742335
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-23
- Public Version
- 2
- Public Version Date
- 2019-02-04
- Public Version Status
- Update
- Public Device Record Key
- 88c8a49b-8441-4e5d-9695-29ea4789a5ae
Device Description
Fructosamine Calibrator
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
- 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 |
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 | 00817238011032 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922904 | 000 |