FDA UDI
In Commercial Distribution
🇺🇸 United States
Elecsys PlGF
DI: 07613336230756
·
Model: 09015418160
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Elecsys PlGF
- Primary DI
- 07613336230756
- Version / Model
- 09015418160
- Catalog Number
- 09015418160
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-07
- Public Version
- 1
- Public Version Date
- 2025-04-15
- Public Version Status
- New
- Public Device Record Key
- 78a743df-0148-4e8a-8a27-2d9405f91972
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| QWH | Prognostic test for development or progression of preeclampsia | Clinical Chemistry | 862.1602 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61081 | Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of soluble vascular endothelial growth factor receptor 1 (sVEGFR-1), also known as soluble fms-like tyrosine kinase 1 (sFlt-1), in a clinical specimen using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336230756 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241453 | 000 |