Identity
- Trade Name
- Prolactin ELISA FDA UDI
- Generic Name
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the quantitative determination of Prolactin in human serum by an enzyme immunoassay. FDA UDI
- Model / Reference
- IB59110 FDA UDI
- Description
- For the quantitative determination of Prolactin in human serum by an enzyme immunoassay. FDA UDI
Identifiers
- Catalog Number
- IB59110 FDA UDI
- Primary DI / UDI-DI
- B652IB59110 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
- 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: Prolactin IVD, kit, enzyme immunoassay (EIA)
Prolactin ELISA by IBL America — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prolactin IVD, kit, enzyme immunoassay (EIA).
- Ansh Labs Prolactin ELISA (CE) — Ansh Labs, LLC
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- PRLs AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- PRL AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA — Ansh Labs, LLC
- Ansh Labs Prolactin ELISA (IVD) — Ansh Labs, LLC
- Prolactin ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- PRLs AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IBL America
Sources (1)
- FDA UDI 1588ab1d-13af-4cb1-bfd6-7fa708ae09ed 36 fields · synced May 30, 2026