FDA UDI
In Commercial Distribution
🇺🇸 United States
Wondfo
DI: 00816862026801
·
Model: DW1-M
·
WONDFO USA CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
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Basic Information
- Brand Name
- Wondfo
- Primary DI
- 00816862026801
- Version / Model
- DW1-M
- Company Name
- WONDFO USA CO., LTD.
- Labeler DUNS
- 849098897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-07-03
- Public Version
- 1
- Public Version Date
- 2025-07-11
- Public Version Status
- New
- Public Device Record Key
- 35eafd98-a3a9-4b53-b208-87b8191b758d
Device Description
1-Midstream; hCG Pregnancy Midstream Test 25 mIU/mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66852 | Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, 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 intended to be used for self-testing by a layperson in the home or similar environment to detect pregnancy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816862026808 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00816862026801 | GS1 | ||||
| Unit of Use | 00816862026795 | GS1 |
Customer Contacts
- Phone
- 630-468-2199
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043443 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius