Identity
- Trade Name
- Follicle Stimulating Hormone (FSH) ELISA FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The FSH ELISA is intended for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders. FDA UDI
- Model / Reference
- EIA-1785 FDA UDI
- Description
- The FSH ELISA is intended for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders. FDA UDI
Identifiers
- Catalog Number
- EIA-1785 FDA UDI
- Primary DI / UDI-DI
- 00840239017857 FDA UDI
- FDA Product Code
- NGA FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1300 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Follicle Stimulating Hormone (FSH) ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- DRG International, Inc.
Sources (1)
- FDA UDI b89e45a3-cf60-4a3a-821f-81a685a11acf 37 fields · synced Jun 8, 2026