Identity
- Trade Name
- Human Growth Hormone (HGH) ELISA FDA UDI
- Generic Name
- Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The HGH ELISA is intended for the quantitative determination of human growth hormone (HGH) concentration in human serum. FDA UDI
- Model / Reference
- EIA-1787 FDA UDI
- Description
- The HGH ELISA is intended for the quantitative determination of human growth hormone (HGH) concentration in human serum. FDA UDI
Identifiers
- Catalog Number
- EIA-1787 FDA UDI
- Primary DI / UDI-DI
- 04048474017878 FDA UDI
- FDA Product Code
- CFL FDA UDI
- GMDN Term
- Multiple thyroid marker 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)
Human Growth Hormone (HGH) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA).
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- Thyroid Stimulating Hormone (TSH) ELISA — DRG International, Inc. · Class II
- Free Triiodothyronine (fT3) ELISA — DRG International, Inc. · Class II
- Total Thyroxine (tT4) ELISA — DRG International, Inc. · Class II
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
Sources (1)
- FDA UDI 6a7fde6d-e05d-4284-a2e6-8af0df8a426d 36 fields · synced May 30, 2026