Identity
- Trade Name
- Be Sure FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
- Device Name
- Menopause Test - 1 Test FDA UDI
- Model / Reference
- Midstream FDA UDI
- Description
- Menopause Test - 1 Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748349000700 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Be Sure by Syntron Bioresearch, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test.
- Rapid Response — BTNX Inc · Class I
- INSTANT-VIEW FSH Dip-Strip Test — Alfa Scientific Designs, Inc. · Class I
- 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
- Follicle stimulating hormone Rapid Test Strip — ASSURE TECH. (HANGZHOU) CO., LTD. · Class I
- INSTANT-VIEW FSH Midstream Cassette Test — Alfa Scientific Designs, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Syntron Bioresearch, Inc.
Sources (1)
- FDA UDI 49647380-64b3-45f4-96cb-4c711ff0608c 33 fields · synced May 31, 2026