FDA UDI
In Commercial Distribution
🇺🇸 United States
Estrone RIA
DI: 15099590211615
·
Model: DSL8700
·
IMMUNOTECH s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Estrone RIA
- Primary DI
- 15099590211615
- Version / Model
- DSL8700
- Catalog Number
- DSL8700
- Company Name
- IMMUNOTECH s.r.o.
- Labeler DUNS
- 360561849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 1
- Public Version Date
- 2023-07-14
- Public Version Status
- New
- Public Device Record Key
- 5889863b-88e6-4455-9161-c048a5e469a5
Device Description
Estrone RIA
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
- 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 |
|---|---|---|---|---|
| CGF | Radioimmunoassay, Estrone | Clinical Chemistry | 862.1280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58373 | Estrone (oestrone) IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estrone (oestrone) 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 | 15099590211615 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935013 | 000 |