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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: —
FDA FEI Number: —
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Catalogue (756)

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Device	Model / Reference	Registries	Class	Status
Anti-FSH-BETA	AM986-5M	FDA UDI	Class I	Active
Anti-Myelin Basic Protein	MU380-UC	FDA UDI	Class I	Active
Anti-Chromogranin A	AM126-10M	FDA UDI	Class I	Active
Anti-Cd 7	AM702-5M	FDA UDI	Class I	Active
i6000™ Diagnostics	AS6030	FDA UDI	Class I	Active
Anti-Cd227	AM534-5M	FDA UDI	Class I	Active
Anti-Myeloperoxidase	PU496-UP	FDA UDI	Class I	Active
Ez-Ar1	HK521-XAK	FDA UDI	Class I	Active
Anti-Chromogranin A	AM126-5M	FDA UDI	Class I	Active
Anti-Cd45 (lca)	AM111-10M	FDA UDI	Class I	Active
Anti-Myf4	MU432-UC	FDA UDI	Class I	Active
Anti-Gfap	PU020-5UP	FDA UDI	Class I	Active
Anti-Cytokeratin17	MU572-UC	FDA UDI	Class I	Active
Anti-Thyroglobulin	AX032-YCD	FDA UDI	Class I	Active
Anti-Cytokeratin 20	AX315-YCD	FDA UDI	Class I	Active
Anti-P504s/Amacr	AN538-5M	FDA UDI	Class I	Active
Willms Tumor Conc Antibody	NU940-UC	FDA UDI	Class I	Active
Anti-Cd99	NU850-UC	FDA UDI	Class I	Active
Anti-Cd2	MU438-UC	FDA UDI	Class I	Active
Cyclin D1	AY815-YCD	FDA UDI	Class I	Active
Anti-Cd20 (b Cell)	AM238-5M	FDA UDI	Class I	Active
Liquid Dab, Chromogen	HK124-100K	FDA UDI	Class I	Active
Anti-S-100 Protein	AR058-5R	FDA UDI	Class I	Active
Anti-EPCAM	AMC16-5M	FDA UDI	Class I	Active
Anti-Prostein	AMB54-5M	FDA UDI	Class I	Active
Anti-C-Erbb-3 (her-3)	MU319-UC	FDA UDI	Class I	Active
Anti-MSH6	AM999-10M	FDA UDI	Class I	Active
Anti-S100B Clone - S100B/1012	AMA15-10M	FDA UDI	Class I	Active
Anti-Cytokeratin 5	NU853-5UC	FDA UDI	Class I	Active
Anti-Gcdfp-15	AM953-5M	FDA UDI	Class I	Active
Anti-P53	AN728-5M	FDA UDI	Class I	Active
Anti-Human Progesterone Receptor (pr)	AN711-5M	FDA UDI	Class I	Active
Anti-Oct 4	AN724-5M	FDA UDI	Class I	Active
Anti-Cd3	AN846-5M	FDA UDI	Class I	Active
Anti-Ki-67 Ag	MU297-5UC	FDA UDI	Class I	Active
Anti-Melanoma Associated Antigen	AM077-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 10	MU201-UC	FDA UDI	Class I	Active
Anti-Glypican-3	MU539-5UC	FDA UDI	Class I	Active
Hsv I	PU084-5UP	FDA UDI	Class I	Active
Anti-Nse	AM055-5M	FDA UDI	Class I	Active
Anti-Cd99	AN850-5M	FDA UDI	Class I	Active
Anti-Cd35	AM431-5M	FDA UDI	Class I	Active
Anti-TFE-3	ANB13-5M	FDA UDI	Class I	Active
Anti-Ema	MU182-5UC	FDA UDI	Class I	Active
Anti-Ca125	MU429-UC	FDA UDI	Class I	Active
Anti-Cd4	MU421-UC	FDA UDI	Class I	Active
Anti-P27	AX396-50D	FDA UDI	Class I	Active
Anti-Pd-1	AM922-5M	FDA UDI	Class I	Active
Anti-Hsa	AM550-5M	FDA UDI	Class I	Active
Anti-Cd45 Cocktail	AM371-5M	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.