FDA UDI
In Commercial Distribution
🇺🇸 United States
Gentian Cystatin C Control Kit (2 x 1mL)
DI: 17090038460020
·
Model: 1019 / A52765
·
Gentian AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gentian Cystatin C Control Kit (2 x 1mL)
- Primary DI
- 17090038460020
- Version / Model
- 1019 / A52765
- Company Name
- Gentian AS
- Labeler DUNS
- 730958121
- 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
- b59fa431-2a2c-42e1-b455-f24d20669bd9
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 |
|---|---|---|---|---|
| NDY | Test, Cystatin C | Clinical Chemistry | 862.1225 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48175 | Cystatin C IVD, control | A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17090038460020 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081875 | 000 |