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Sign in to claim this brandBiogenex Laboratories, Inc.
US
Last updated May 23, 2026
What Biogenex Laboratories, Inc. makes
Biogenex Laboratories, Inc. manufactures in vitro diagnostic (IVD) antibodies targeting specific cellular and tissue markers, including cytokeratin, Ki67, progesterone receptor, synaptophysin, chromogranin A, CD45, and CD31. Their portfolio also includes antibodies for melanoma-associated antigens (e.g., MELAN-A, MUM1/IRF4) and viral markers (e.g., adenovirus). Additionally, the company produces automated microscope slide staining systems for immunohistochemistry applications.
The company’s products are classified under FDA’s In Vitro Diagnostic Device regulations, with devices falling into Class I and Class II categories. These antibodies and staining systems are listed in the FDA’s Unique Device Identifier (UDI) database. Biogenex Laboratories, Inc. 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 Biogenex Laboratories, Inc. manufacture?
Biogenex Laboratories, Inc. specializes in in vitro diagnostic (IVD) devices, primarily antibodies designed for immunohistochemistry. These antibodies target specific cellular and tissue markers such as cytokeratin, Ki67, progesterone receptors, synaptophysin, chromogranin A, CD45, CD31, and melanoma-associated antigens like MELAN-A and MUM1/IRF4. The company also produces automated microscope slide staining systems, which assist in the visualization of these markers for diagnostic purposes.
Where is Biogenex Laboratories, Inc. based?
Biogenex Laboratories, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as its devices are designed and manufactured under U.S. regulatory oversight.
Which regulatory registries list Biogenex Laboratories, Inc.’s devices?
Biogenex Laboratories, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Biogenex Laboratories, Inc.’s devices classified under FDA regulations?
Biogenex’s devices fall under the FDA’s In Vitro Diagnostic Device regulations and are classified as either Class I or Class II. Class I devices generally pose minimal risk and require less regulatory scrutiny, while Class II devices involve moderate risk and may require specific controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (756)
Page 16 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biogenex Monoclonal Anti-Estrogen Receptor(clone Er88) | K013148 | FDA 510(k) | Class II | Active |
| Riagen B-Hcg Ria | K821657 | FDA 510(k) | Class II | Active |
| Pregnagen 1-Step Pregnancy Test | K925189 | FDA 510(k) | Class II | Active |
| Ovugen Suretest | K873534 | FDA 510(k) | Class I | Active |
| Riagen B-Hcg Ria Kit | K831221 | FDA 510(k) | Class II | Active |
| Insite Her-2/Neu Kit | P040030 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (11)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biogenex Laboratories, Inc. has 11 recall records initiated between February 9, 2006, and July 1, 2014, all of which are recorded as terminated. The reasons cited include potential product system failures that could cause operator exposure to Hemo-De solution, distribution without 510(k) approval, misbranding and mislabeling issues related to non-compliance with Analyte Specific Reagent (ASR) requirements, incorrect labeling of reagent contents and antibody cocktails, and a defective bulk reagent dispensing mechanism that could result in spills.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 1, 2014 | Z-2113-2014 | — | terminated | Product was distributed without 510(k) approval. |
| Jan 23, 2009 | Z-1016-2010 | — | terminated | Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution. |
| Jan 24, 2008 | Z-1471-2008 | — | terminated | Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals. |
| Oct 3, 2006 | Z-0217-2007 | — | terminated | Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled. |
| Sep 5, 2006 | Z-1519-06 | — | terminated | Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67. |
| Jun 2, 2006 | Z-1439-06 | — | terminated | Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific |
| Jun 2, 2006 | Z-1438-06 | — | terminated | Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific Reagent (ASR). |
| Feb 9, 2006 | Z-0608-06 | — | terminated | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| Feb 9, 2006 | Z-0609-06 | — | terminated | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| Feb 9, 2006 | Z-0606-06 | — | terminated | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| Feb 9, 2006 | Z-0607-06 | — | terminated | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |