FDA UDI
In Commercial Distribution
🇺🇸 United States
Wondfo
DI: 00816862026436
·
Model: DW199-S-6BX-A
·
WONDFO USA CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- Wondfo
- Primary DI
- 00816862026436
- Version / Model
- DW199-S-6BX-A
- Company Name
- WONDFO USA CO., LTD.
- Labeler DUNS
- 849098897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2024-12-24
- Public Version
- 1
- Public Version Date
- 2025-01-01
- Public Version Status
- New
- Public Device Record Key
- 5624c49d-db60-45a2-b972-9df78d348e4c
Device Description
6-Strip; PDG Progesterone test
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QKE | Immunoassay, Pregnanediol Glucuronide, Over The Counter | Clinical Chemistry | 862.1620 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65241 | Multiple female fertility marker IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a combination of different types of female fertility markers [e.g., estrone-3-glucuronide (E1-3G), pregnanediol-3-glucuronide (PdG), luteinizing hormone (LH) and follicle stimulating hormone (FSH)] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816862026433 | GS1 | 160 | In Commercial Distribution | ||
| Primary | 00816862026436 | GS1 | ||||
| Unit of Use | 00816862026429 | GS1 |
Customer Contacts
- Phone
- 630-468-2199
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius