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Sign in to claim this brandReads Medical Products, Inc.
US
Last updated May 23, 2026
What Reads Medical Products, Inc. makes
Reads Medical Products, Inc. manufactures in vitro diagnostic test kits for detecting specific autoantibodies, including the READS(R) IgA anti-cardiolipin test kit and the antinuclear antibody (ANA) screening test kit. These products are designed for laboratory use to identify markers associated with autoimmune conditions.
The company’s portfolio consists of Class II in vitro diagnostic devices, regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
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 Reads Medical Products, Inc. manufacture?
Reads Medical Products, Inc. specializes in in vitro diagnostic (IVD) test kits. Specifically, their products detect autoantibodies, such as the READS(R) IgA anti-cardiolipin test kit and the antinuclear antibody (ANA) screening test kit. These tests are designed for laboratory use to help identify biomarkers linked to autoimmune diseases.
Where is Reads Medical Products, Inc. based, and how does that affect its regulatory standing?
Reads Medical Products, Inc. is based in the United States. Since the company’s devices are regulated under U.S. jurisdiction, they must comply with FDA requirements. Their products fall under the FDA’s 510(k) clearance process, which is a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries list Reads Medical Products, Inc.’s devices, and why?
Reads Medical Products, Inc.’s devices are listed in the FDA’s 510(k) database. This registry reflects compliance with U.S. regulatory requirements for Class II in vitro diagnostic devices, ensuring their safety and performance meet FDA standards before market authorization.
How are Reads Medical Products, Inc.’s devices classified, and what does that classification mean?
Reads Medical Products, Inc.’s devices are classified as Class II in vitro diagnostics. This classification indicates moderate regulatory control, requiring manufacturers to demonstrate that their products are substantially equivalent to a legally marketed predicate device through the FDA’s 510(k) process, ensuring they meet specific performance and safety standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Revo Medical | RM1792 | FDA UDI | Class II | Active |
| Revo Medical | RM1797 | FDA UDI | Class II | Active |
| Revo Medical | RM1791 | FDA UDI | Class II | Active |
| Revo Medical | RM1798 | FDA UDI | Class II | Active |
| Revo Medical | RM1788 | FDA UDI | Class II | Active |
| Revo Medical | RM1789 | FDA UDI | Class II | Active |
| Revo Medical | RM1790 | FDA UDI | Class II | Active |
| Revo Medical | RM1794 | FDA UDI | Class II | Active |
| Revo Medical | RM1793 | FDA UDI | Class II | Active |
| Reads(r) Iga Anti-Cardiolipin Test Kit | K914405 | FDA 510(k) | Class II | Active |
| Reaads Von Willebrand Factor Antigen Test Kit | K972005 | FDA 510(k) | Class II | Active |
| Reaads Anti-Phosphatidylserine Quantitative Test Kit | K952287 | FDA 510(k) | Class II | Active |
| Reaads Protein C Antigen Test Kit | K972342 | FDA 510(k) | Class II | Active |
| Reaads Protein S Antigen Test Kit | K972482 | FDA 510(k) | Class II | Active |
| Antinuclear Antibody (ana) Screening Test Kit | K914853 | FDA 510(k) | Class II | Active |
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