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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
Address: —
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EUDAMED SRN: —
FDA FEI Number: —
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Catalogue (756)

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Device	Model / Reference	Registries	Class	Status
Anti-Ema	AM182-5M	FDA UDI	Class I	Active
Super Sensitive Wash Buffer	HK583-5K	FDA UDI	Class I	Active
Anti-Bcl-2	AN723-5M	FDA UDI	Class I	Active
Anti-PR (Insite)	MU328-UC	FDA UDI	Class II	Active
Anti-Hsv I	AR084-5R	FDA UDI	Class I	Active
Anti- FLI-1	AMB24-5M	FDA UDI	Class I	Active
Anti- Estrogen Receptor-Alpha	NU710-5UC	FDA UDI	Class I	Active
Anti-Vimentin	AM074-10M	FDA UDI	Class I	Active
Anti-Beta-Hcg	MU395-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 7	AM255-10M	FDA UDI	Class I	Active
Anti-Gfap	AM020-5M	FDA UDI	Class I	Active
Anti-Msh6	MU999-UC	FDA UDI	Class I	Active
Anti-Myosin	AM109-5M	FDA UDI	Class I	Active
Anti-OCT-3/4	AMB84-5M	FDA UDI	Class I	Active
Anti-Insulin	AM029-5M	FDA UDI	Class I	Active
Anti-Luteinizing Hormone	AN787-5M	FDA UDI	Class I	Active
Anti-Inhibin Alpha	AM446-5M	FDA UDI	Class I	Active
Pipette Tips (Blue)	XT153-10X	FDA UDI	Class I	Active
Anti-ER (Insite)	MU368-5UC	FDA UDI	Class II	Active
P27 (kip1)	AY817-YCD	FDA UDI	Class I	Active
Anti-Her2/Erbb2	AN726-10M	FDA UDI	Class I	Active
Anti- Cytokeratin Hmw	AM133-5M	FDA UDI	Class I	Active
Anti-Cd20	MU537-UC	FDA UDI	Class I	Active
Cd56 (natural Killer Cell, Ncam)	AM268-10M	FDA UDI	Class I	Active
Anti-Cd43	MU305-UC	FDA UDI	Class I	Active
Anti-Cd34	MU236-5UC	FDA UDI	Class I	Active
Anti-SOX10	AM995-10M	FDA UDI	Class I	Active
Anti-Egfr	AN781-5M	FDA UDI	Class I	Active
Anti-Cd68	MU549-UC	FDA UDI	Class I	Active
Anti-Pdl-1	AN921-5M	FDA UDI	Class I	Active
Anti-Estrogen Receptor-Alpha	NU710-UC	FDA UDI	Class II	Active
Anti-Oct-2	NU830-UC	FDA UDI	Class I	Active
Anti-Myosin Heavy Chain	MU331-UC	FDA UDI	Class I	Active
Anti- Oct-4	NU724-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 8	AM142-5M	FDA UDI	Class I	Active
Anti-P504s	AN449-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 5	AN847-5M	FDA UDI	Class I	Active
Anti-Cd66	AM325-5M	FDA UDI	Class I	Active
Anti-Vegf	AR483-5R	FDA UDI	Class I	Active
Anti-Human Progesterone Receptor	AN711-10M	FDA UDI	Class I	Active
Anti-Nse	MU055-UC	FDA UDI	Class I	Active
Anti-ER (Insite)	AM368-10M	FDA UDI	Class II	Active
Pipette Tips	XT145-05X	FDA UDI	Class I	Active
Anti- IDH1	AMA22-5M	FDA UDI	Class I	Active
Anti-P53 Protein	AM239-10M	FDA UDI	Class I	Active
Anti-Fascin	AM488-5M	FDA UDI	Class I	Active
Anti-Laminin	PU078-UP	FDA UDI	Class I	Active
Anti-C-Erbb-2 (her-2/Neu)	AM134-5M	FDA UDI	Class I	Active
Anti-Cytomegalovirus (CMV)	MU997-UC	FDA UDI	Class I	Active
Anti-Hla-Dr	MU154-UC	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.