Identity
- Trade Name
- Human Growth Hormone ELISA FDA UDI
- Generic Name
- Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Glucagon ELISA is for the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
- Model / Reference
- 11-HGHHU-E01 FDA UDI
- Description
- The Glucagon ELISA is for the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 11-HGHHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24211HGHHUE010 FDA UDI
- FDA Product Code
- CFL FDA UDI
- GMDN Term
- Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA) 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA)
Human Growth Hormone ELISA by American Laboratory Products Company — 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
- American Laboratory Products Company
Sources (1)
- FDA UDI 1a758c8c-67d3-45f3-a6d0-236ff2a7420f 35 fields · synced Jun 1, 2026