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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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Catalogue (756)

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Device	Model / Reference	Registries	Class	Status
Anti-Toxoplasma	PU125-UP	FDA UDI	Class I	Active
Anti-Cyclin D1	AR447-5R	FDA UDI	Class I	Active
Anti-p40	ANA43-5M	FDA UDI	Class I	Active
Anti-S100 Beta	AN713-5M	FDA UDI	Class I	Active
Anti-Cd117/C-Kit/Scf	AR759-5R	FDA UDI	Class I	Active
Anti-Gfap	MU020-UC	FDA UDI	Class I	Active
Anti-Cd10	MU451-UC	FDA UDI	Class I	Active
Xmatrx® Infinity	AS4000RX	FDA UDI	Class I	Active
Anti-Cd21	AN745-5M	FDA UDI	Class I	Active
Anti-Cd16a	AN749-5M	FDA UDI	Class I	Active
Anti-Cytokeratin	AM291-5M	FDA UDI	Class I	Active
Anti-Kappa Light Chain	AM980-5M	FDA UDI	Class I	Active
Anti-Androgen Receptor	MU256-UC	FDA UDI	Class I	Active
Anti-Ki67	AM410-5M	FDA UDI	Class I	Active
P53[ep9]	AY728-YCD	FDA UDI	Class I	Active
Anti-Cd21	AN825-5M	FDA UDI	Class I	Active
25x40 Coverslips	XT118-50X	FDA UDI	Class I	Active
Anti-Brca1 Protein	AR345-5R	FDA UDI	Class I	Active
Anti-Alk	AN874-5M	FDA UDI	Class I	Active
Anti-Prolactin	AM978-5M	FDA UDI	Class I	Active
Anti-Cytokeratin, Pan	MU181-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 18	MU143-UC	FDA UDI	Class I	Active
Anti-Actin	MU128-UC	FDA UDI	Class I	Active
Anti-Tag-72	MU054-UC	FDA UDI	Class I	Active
Anti-Bcl6	AM708-5M	FDA UDI	Class I	Active
Anti- C4D	AR572-5R	FDA UDI	Class I	Active
Anti-MYF-4	MU987-UC	FDA UDI	Class I	Active
Anti-Mucin-2 (muc-2)	AM358-5M	FDA UDI	Class I	Active
Anti-Sox2	NU833-5UC	FDA UDI	Class I	Active
Anti-Cd2	AM438-5M	FDA UDI	Class I	Active
Anti-Cd41/Integrin	AN732-5M	FDA UDI	Class I	Active
Anti-Dog1	AM570-10M	FDA UDI	Class I	Active
Anti-Laminin	AR078-5R	FDA UDI	Class I	Active
Anti-CD163	AMA02-5M	FDA UDI	Class I	Active
Anti-CD105	AM990-5M	FDA UDI	Class I	Active
Anti-Pms2	NU844-UC	FDA UDI	Class I	Active
Anti-Myoglobin	AM012-5M	FDA UDI	Class I	Active
Anti-Cd117	MU423-5UC	FDA UDI	Class I	Active
Anti-hGH	MU028-UC	FDA UDI	Class I	Active
Anti-Cd 23	PU460-UP	FDA UDI	Class I	Active
Anti-Cd1a	MU490-5UC	FDA UDI	Class I	Active
p16 (INK4a)	AX540-YCD	FDA UDI	Class I	Active
Anti-Cytokeratin 14	MU146-UC	FDA UDI	Class I	Active
Anti-Estrogen Receptor-Alpha	AN710-5M	FDA UDI	Class I	Active
Androgen Receptor	AM256-5M	FDA UDI	Class I	Active
Anti-Plap	AM228-5M	FDA UDI	Class I	Active
Anti-P16(ink4)	AM540-10M	FDA UDI	Class I	Active
Anti-Melanoma	AX001-YCD	FDA UDI	Class I	Active
Anti-Estrogen Receptor-Alpha	AN710-10M	FDA UDI	Class I	Active
Anti-Mum1/Irf4	NU750-UC	FDA UDI	Class I	Active

Related Companies

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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.