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Sign in to claim this brandIBL America
US
Last updated May 30, 2026
What IBL America makes
IBL America manufactures in vitro diagnostic (IVD) enzyme-linked immunosorbent assay (ELISA) kits for hormone testing, including estrone, free testosterone, pregnenolone, prolactin, and total estrogen. These products are designed for laboratory use to quantify specific steroid and peptide hormones in biological samples. The assays are provided as ready-to-use kits for enzyme immunoassay (EIA) applications.
The company’s diagnostic products fall under Class I regulatory classification in the U.S. and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use within the United States, adhering to applicable FDA requirements for in vitro diagnostics.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does IBL America manufacture?
IBL America produces in vitro diagnostic (IVD) enzyme-linked immunosorbent assay (ELISA) kits for hormone testing, including estrone, free testosterone, pregnenolone, prolactin, and total estrogen. These kits are designed for laboratory use to quantify specific steroid and peptide hormones in biological samples.
Where is IBL America based?
IBL America is based in the United States. The company manufactures and distributes its diagnostic products within the U.S., adhering to applicable FDA requirements for in vitro diagnostics.
Which regulatory registries list IBL America's devices?
IBL America's devices are listed in the FDA's Unique Device Identifier (UDI) database. This registry provides information about medical devices, including their identification and classification, as required by U.S. regulations.
How are IBL America's devices classified?
IBL America's diagnostic products fall under Class I regulatory classification in the U.S. Class I devices are considered low-risk and are subject to general controls, which include adherence to labeling, performance standards, and UDI requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ibl-america.com
- —
- —
- [email protected]
- Phone
- 888-523-1246
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 159853449
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Salivary Cortisol ELISA | IB79305 | FDA UDI | Class II | Unknown |
| Estrone ELISA | IB59105 | FDA UDI | Class I | Active |
| Pregnenolone ELISA | IB59107 | FDA UDI | Class I | Active |
| Prolactin ELISA | IB59110 | FDA UDI | Class I | Active |
| Testosterone (Free) ELISA | IB59109 | FDA UDI | Class I | Active |
| Total Estrogens ELISA | IB59134 | FDA UDI | Class I | Active |
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