FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoDELFIA Unconjugated Estriol (uE3) kit
DI: 06438147355013
·
Model: B095-101U
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AutoDELFIA Unconjugated Estriol (uE3) kit
- Primary DI
- 06438147355013
- Version / Model
- B095-101U
- Catalog Number
- B095-101U
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 1
- Public Version Date
- 2018-12-17
- Public Version Status
- New
- Public Device Record Key
- dd5363b1-b402-4a04-9013-7a658c154f48
Device Description
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
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
- 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 |
|---|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | Clinical Chemistry | 862.1265 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62124 | Free estriol (oestriol) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a fluorescent immunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147355013 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius