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Follicle stimulating hormone Rapid Test Strip
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Follicle stimulating hormone Rapid Test Strip FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06952804801519 FDA UDI
- FDA Product Code
- NGA FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Follicle stimulating hormone Rapid Test Strip by Assure Tech. (hangzhou) Co., Ltd. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test.
- Rapid Response — BTNX Inc · Class I
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- Walgreens — WALGREEN CO. · Class I
- One Step Menopausal Test — UNIVERSAL MEDITECH INC. · Class I
- INSTANT-VIEW FSH Cassette Test — Alfa Scientific Designs, Inc. · Class I
- INSTANT-VIEW FSH Midstream Cassette Test, 2t — Alfa Scientific Designs, Inc. · Class I
- INSTANT-VIEW FSH Midstream Cassette Test — Alfa Scientific Designs, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Assure Tech. (hangzhou) Co., Ltd.
Sources (2)
- FDA UDI 6ac1bff0-c903-4348-b08a-ca913bb8300f 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026