Identity
- Trade Name
- Prolactin ELISA FDA UDI
- Generic Name
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus. FDA UDI
- Model / Reference
- EIA-1786 FDA UDI
- Description
- The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus. FDA UDI
Identifiers
- Catalog Number
- EIA-1786 FDA UDI
- Primary DI / UDI-DI
- 00840239017864 FDA UDI
- FDA Product Code
- CFT FDA UDI
- GMDN Term
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1625 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
Prolactin 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 69c23028-600e-4cf6-8f7c-1344de61ff48 37 fields · synced May 30, 2026