FDA UDI
In Commercial Distribution
🇺🇸 United States
11-DESOXYCORTISOL-RIA-CT
DI: 05400569000650
·
Model: KIPI20000
·
Diasource Immunoassays S.A. SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 11-DESOXYCORTISOL-RIA-CT
- Primary DI
- 05400569000650
- Version / Model
- KIPI20000
- Company Name
- Diasource Immunoassays S.A. SA
- Labeler DUNS
- 458777323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-15
- Public Version
- 1
- Public Version Date
- 2020-09-23
- Public Version Status
- New
- Public Device Record Key
- b864f9b8-d801-4afb-9a74-80c2fef9ea8a
Device Description
11-DESOXYCORTISOL-RIA-CT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKB | RADIOIMMUNOASSAY, COMPOUND S (11-DEOXYCORTISOL) | Clinical Chemistry | 862.1185 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54027 | 11-Deoxycortisol IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 11-deoxycortisol in a clinical specimen, using a radioimmunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05400569000650 | GS1 |