FDA UDI
In Commercial Distribution
🇺🇸 United States
Estrone-sulfate RIA
DI: 15099590211547
·
Model: DSL5400
·
IMMUNOTECH s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Estrone-sulfate RIA
- Primary DI
- 15099590211547
- Version / Model
- DSL5400
- Catalog Number
- DSL5400
- 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
- 4622e79a-d589-4644-94df-68149ff87033
Device Description
Estrone-sulfate 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 |
|---|---|---|---|---|
| 58368 | Estrone sulfate (oestrone sulfate) 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 sulfate (oestrone sulfate) 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 | 15099590211547 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970915 | 000 |