Identity
- Trade Name
- HGH-US FDA UDI
- Generic Name
- Human growth hormone (HGH) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- Radioimmunometric assay kit for the quantitative determination of human growth hormone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic. FDA UDI
- Model / Reference
- HGH-US FDA UDI
- Description
- Radioimmunometric assay kit for the quantitative determination of human growth hormone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic. FDA UDI
Identifiers
- Catalog Number
- HGH-US FDA UDI
- Primary DI / UDI-DI
- 03770024321562 FDA UDI
- FDA Product Code
- CFL FDA UDI
- GMDN Term
- Human growth hormone (HGH) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Category: Human growth hormone (HGH) IVD, kit, radioimmunoassay
Hgh-Us by Cisbio Bioassays — 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
- Cisbio Bioassays
Sources (1)
- FDA UDI f7acd9e6-8525-45df-a562-c4dff080d197 36 fields · synced May 30, 2026