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Sign in to claim this brandPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
US
Last updated May 23, 2026
What POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC makes
The company manufactures in vitro diagnostics (IVDs) for detecting faecal occult blood, including reagent strips, rapid immunochemical test (ICT) kits, and immunoassay analysers. It also produces controls, calibrators, and kits for bladder tumour-associated antigen testing, including rapid ICT and enzyme immunoassay (EIA) formats.
These products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Polymedco Cancer Diagnostic Products LLC manufacture?
Polymedco Cancer Diagnostic Products LLC specializes in in vitro diagnostics (IVDs) primarily focused on detecting faecal occult blood. Their product line includes reagent strips, rapid immunochemical test (ICT) kits, immunoassay analysers, controls, and calibrators. Additionally, they offer kits for detecting bladder tumour-associated antigen, including rapid ICT and enzyme immunoassay (EIA) formats. These devices are designed for clinical use in diagnostic settings.
Where is Polymedco Cancer Diagnostic Products LLC based?
The company is headquartered in the United States. This location is relevant for regulatory compliance, as it influences the jurisdiction under which their devices may be authorised and monitored.
How are the devices manufactured by Polymedco Cancer Diagnostic Products LLC classified?
All devices produced by Polymedco Cancer Diagnostic Products LLC fall under the classification of Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device’s intended use and design. Class II devices typically require special controls in addition to general controls to ensure their safety and effectiveness.
Are the devices listed in any regulatory registries?
Yes, the devices manufactured by Polymedco Cancer Diagnostic Products LLC are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory oversight.
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
- 078413594
Catalogue (769)
Page 16 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OC-Auto | OCPU-GHG | FDA UDI | Class II | Active |
| OC-Light S | FBPUS-OMC | FDA UDI | Class II | Active |
| OC-Auto | OCPU-ANMC | FDA UDI | Class II | Active |
| OC-Auto | OCPU-UTS-R | FDA UDI | Class II | Active |
| OC-Auto | OCS2-CCO | FDA UDI | Class II | Active |
| OC-Auto | OCPU-LAWV | FDA UDI | Class II | Active |
| OC-Auto | OCPU-UCINN | FDA UDI | Class II | Active |
| OC-Auto | OCPUIO-LIFE | FDA UDI | Class II | Active |
| OC-Auto | OCPU-ML | FDA UDI | Class II | Active |
| BTA stat | 661510 | FDA UDI | Class II | Active |
| OC-Auto | OCPUIO-UAB | FDA UDI | Class II | Active |
| OC-Auto | OCPUIO-DHMC | FDA UDI | Class II | Active |
| OC-Auto | OCPUIO-VA1 220600 | FDA UDI | Class II | Active |
| OC-Auto | OCPU-THNE | FDA UDI | Class II | Active |
| OC-Auto | OCPU-VA1 917010 | FDA UDI | Class II | Active |
| OC-Auto | OCPU-VA1 915894 | FDA UDI | Class II | Active |
| OC-Auto | OCPU-QDEN | FDA UDI | Class II | Active |
| OC-Auto | OCPU-ALAM | FDA UDI | Class II | Active |
| OC-Auto | OCPU-KPS FT | FDA UDI | Class II | Active |
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