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Sign in to claim this brandVITRO SA
US
Last updated May 24, 2026
What VITRO SA makes
Vitro SA produces reagents and solutions for in vitro diagnostic (IVD) use in immunohistochemistry, including antigen retrieval solutions like pepsin for tissue preparation, antibody detection reagents for staining, and buffer solutions such as TBS Tween 20 and phosphate/Sorenson buffers. Their portfolio also includes dual staining kits designed for simultaneous detection of multiple targets in tissue samples.
These products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory standards 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 types of medical devices does Vitro SA manufacture?
Vitro SA specializes in in vitro diagnostic (IVD) reagents and solutions primarily used in immunohistochemistry. Their products include antigen retrieval reagents like pepsin for preparing tissue samples, antibody detection reagents for staining, buffer solutions such as TBS Tween 20 and phosphate/Sorenson buffers, and dual staining kits for detecting multiple targets simultaneously in tissue samples.
Where is Vitro SA based, and what regulatory standards do they follow?
Vitro SA is based in the United States. Their devices are developed and marketed in compliance with U.S. regulatory standards for in vitro diagnostics, though individual products must undergo their own authorization process to meet FDA requirements.
Which regulatory registries list Vitro SA’s devices?
Vitro SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry provides a standardized identifier for their Class I medical devices, ensuring traceability and transparency in the regulatory landscape.
How are Vitro SA’s devices classified under FDA regulations?
Vitro SA’s devices fall under Class I classification according to FDA regulations. This classification applies to low-risk in vitro diagnostics, including reagents and buffers used in immunohistochemistry, which generally pose minimal risk to patients when used as intended.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 466076718
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TBS Tween 20 Buffer 10X q.s. 10L | MAD-004077R-10 | FDA UDI | Class I | Active |
| Pepsin for antigen retrieval (RTU) | MAD-024081RVS | FDA UDI | Class I | Active |
| Master Dual Staining Kit | MAD-001882QPVSBC | FDA UDI | Class I | Active |
| Master Dual Staining Kit | MAD-001882QPVS | FDA UDI | Class I | Active |
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