Identity
- Trade Name
- Prolactin ELISA FDA UDI
- Generic Name
- Prolactin IVD, calibrator FDA UDI
- Device Name
- The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagnostic use in the United States of America. For research use only in other territories. FDA UDI
- Model / Reference
- 20-PROHU-E01 FDA UDI
- Description
- The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagnostic use in the United States of America. For research use only in other territories. FDA UDI
Identifiers
- Catalog Number
- 20-PROHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24220PROHUE010 FDA UDI
- FDA Product Code
- CFT FDA UDI
- GMDN Term
- Prolactin IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1625 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
No
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: Prolactin IVD, calibrator
Prolactin 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 b367c64b-376a-41c1-bfca-3af422341b52 36 fields · synced May 30, 2026