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Biogenex Laboratories, Inc.

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

Country: US
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EUDAMED SRN: —
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Catalogue (756)

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Device	Model / Reference	Registries	Class	Status
Anti-Cytokeratin PAN	AMA46-5M	FDA UDI	Class I	Active
Proteinase K Reagent	HK878-5K	FDA UDI	Class I	Active
Anti-Cd99	AM355-5M	FDA UDI	Class I	Active
Anti-Cd20 (b Cell)	MU238A-5UC	FDA UDI	Class I	Active
Anti-Chromogranin A	MU126-UC	FDA UDI	Class I	Active
Anti-Cd117	AM423-10M	FDA UDI	Class I	Active
Anti-E-Cadherin	MU390-UC	FDA UDI	Class I	Active
Anti-Msh2	NU743-UC	FDA UDI	Class I	Active
ANTI-Mum1/IRF4	AN750-5M	FDA UDI	Class I	Active
Anti-Erg	NU782-UC	FDA UDI	Class I	Active
Anti-Melanoma Assoc. Ag	AM077-10M	FDA UDI	Class I	Active
Anti-P504s	AN449-5M	FDA UDI	Class I	Active
Anti-Cytokeratin	AM273-5M	FDA UDI	Class I	Active
Anti-Cyclin D1	AN815-10M	FDA UDI	Class I	Active
Pipette Tips, 200 µL	XT146-01X	FDA UDI	Class I	Active
Anti-Pms2	AN844-5M	FDA UDI	Class I	Active
Anti-Androgen Receptor	MU256-5UC	FDA UDI	Class I	Active
Anti-Cytokeratin 8 &18	AM131-5M	FDA UDI	Class I	Active
Anti-Cd68	AM549-5M	FDA UDI	Class I	Active
Anti-C-Erbb-2	NU753-UC	FDA UDI	Class I	Active
Anti-Ebv	AM222-5M	FDA UDI	Class I	Active
Anti-Cd45ro (t-Cell)	AM113-5M	FDA UDI	Class I	Active
Anti- Cytokeratin Hmw	MU133-UC	FDA UDI	Class I	Active
Anti-Cd7	AM702-5M	FDA UDI	Class I	Active
Anti-Oct-2	AN830-5M	FDA UDI	Class I	Active
Anti-Neurofilament	AM073-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 7	MU255-UC	FDA UDI	Class I	Active
Anti-Beta Catenin	NU778-UC	FDA UDI	Class I	Active
p53 Protein	AM240-5M	FDA UDI	Class I	Active
Anti-E-Cadherin	AM390-5M	FDA UDI	Class I	Active
Anti-Cd8	NU740-UC	FDA UDI	Class I	Active
Anti-Breast Ca. Ag. Bca-225	AM135-5M	FDA UDI	Class I	Active
Anti-Caldesmon Hmw	MU332-UC	FDA UDI	Class I	Active
Anti-CD45RO (T Cell)	MU113-UC	FDA UDI	Class I	Active
Anti-Lambda Light Chain	AR049-5R	FDA UDI	Class I	Active
Anti-Lysozyme	AR024-10R	FDA UDI	Class I	Active
Anti-Cd79a	AM414-5M	FDA UDI	Class I	Active
Anti-Mlh 1	AM703-10M	FDA UDI	Class I	Active
Anti-C-Kit/Cd117	NU818-UC	FDA UDI	Class I	Active
Anti-Cd61	AM942-5M	FDA UDI	Class I	Active
Anti-Cd35	AN741-5M	FDA UDI	Class I	Active
Anti-P63	MU418-5UC	FDA UDI	Class I	Active
Anti-Cytokeratin 20	AN849-5M	FDA UDI	Class I	Active
Anti-Dog1	MU570-UC	FDA UDI	Class I	Active
Anti-Glut-1	MU505-UC	FDA UDI	Class I	Active
Anti-Ki-67	AM370-5M	FDA UDI	Class I	Active
Anti-PAX8	ANB31-5M	FDA UDI	Class I	Active
25 X 25 Coverslips	XT122-YQK	FDA UDI	Class I	Active
Anti-Calponin	MU333-UC	FDA UDI	Class I	Active
Inhibin Alpha	MU446-UC	FDA UDI	Class I	Active

Related Companies

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Notified Bodies

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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.