Identity
- Trade Name
- hGH-IRMA FDA UDI
- Generic Name
- Human growth hormone (HGH) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- hGH-IRMA FDA UDI
- Model / Reference
- KIP1081 FDA UDI
- Description
- hGH-IRMA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05400569000407 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
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
Category: Human growth hormone (HGH) IVD, kit, radioimmunoassay
hGH-IRMA by Diasource Immunoassays, S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human growth hormone (HGH) IVD, kit, radioimmunoassay.
- HGH-US — CISBIO BIOASSAYS · Class I
- KIP1131 — Diasource Immunoassays, S.A. · 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
- Diasource Immunoassays, S.A.
Sources (1)
- FDA UDI a1f8d735-c8ed-4d6a-a722-be6b35a70c25 33 fields · synced Jun 8, 2026