Identity
- Trade Name
- INSTANT-VIEW FSH Dip-Strip Test FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test FDA UDI
- Device Name
- INSTANT-VIEW FSH Dip-Strip Test FDA UDI
- Model / Reference
- 02-2567 FDA UDI
- Description
- INSTANT-VIEW FSH Dip-Strip Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10796918000146 FDA UDI
- FDA Product Code
- CGJ 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
INSTANT-VIEW FSH Dip-Strip Test by Alfa Scientific Designs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Alfa Scientific Designs, Inc.
Sources (1)
- FDA UDI 17039b30-45d5-4124-b531-c1bcb6e294c7 33 fields · synced Jun 9, 2026