FDA UDI
In Commercial Distribution
🇺🇸 United States
One Step FSH Rapid Test Dipstick (Urine)
DI: 06942598202326
·
Model: 1
·
Hangzhou AllTest Biotech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- One Step FSH Rapid Test Dipstick (Urine)
- Primary DI
- 06942598202326
- Version / Model
- 1
- Company Name
- Hangzhou AllTest Biotech Co., Ltd.
- Labeler DUNS
- 543254717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2025-10-10
- Public Version
- 1
- Public Version Date
- 2025-10-20
- Public Version Status
- New
- Public Device Record Key
- 7825d3bb-dea3-4ed4-a503-16d9f8baf670
Device Description
One Step FSH Rapid Test Dipstick (Urine), 20T/bag; EN/SP
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
- 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 |
|---|---|---|---|---|
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Clinical Chemistry | 862.1300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65840 | Follicle stimulating hormone (FSH) 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 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 as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility). 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 86942598202322 | GS1 | ||||
| Primary | 06942598202326 | GS1 |