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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-Cd4	AM421-5M	FDA UDI	Class I	Active
Anti-Cd10	AM451-10M	FDA UDI	Class I	Active
Anti-Pcna	MU252-UC	FDA UDI	Class I	Active
Anti-Msh6	AM999-5M	FDA UDI	Class I	Active
Anti-Melanoma Gp100	AM536-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 14	MU146-5UC	FDA UDI	Class I	Active
Anti-Muc4	AM455-5M	FDA UDI	Class I	Active
Anti-Adenovirus	AM059-5M	FDA UDI	Class I	Active
Anti-Melan-A	AM361-5M	FDA UDI	Class I	Active
Anti-Human Mum1/Irf4	NU750-5UC	FDA UDI	Class I	Active
Anti-Alpha-1-Antitrypsin	AR015-5R	FDA UDI	Class I	Active
Anti-Cd22	MU962-UC	FDA UDI	Class I	Active
Anti-Myoglobin	MU012-5UC	FDA UDI	Class I	Active
Anti-SALL4	AMB18-5M	FDA UDI	Class I	Active
Pipette tip, Combo, 200ul	XT156-06X	FDA UDI	Class I	Active
Anti-Epithelial-Sp. Ag	AM316-5M	FDA UDI	Class I	Active
Liquid Dab Chromogen	HK124-05K	FDA UDI	Class I	Active
Anti-Cd117	MU423-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 20	MU315-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 19	AM246-10M	FDA UDI	Class I	Active
Anti-Gata-3	AMB89-5M	FDA UDI	Class I	Active
Pepsin 3-Pack Kit	EK000-5K	FDA UDI	Class I	Active
Anti-Cytokeratin17	AM572-5M	FDA UDI	Class I	Active
Anti-Pms2	AN844-10M	FDA UDI	Class I	Active
Anti-Cd71	MU354-UC	FDA UDI	Class I	Active
Anti-Cd138	NU837-UC	FDA UDI	Class I	Active
Anti-P16(ink4)	AM540-10M	FDA UDI	Class I	Active
Anti-Toxoplasma Gondii	AR125-5R	FDA UDI	Class I	Active
ANTI-Anti-EBV/LMP-1	MUA66-UC	FDA UDI	Class I	Active
Anti-Hgh	AR707-5R	FDA UDI	Class I	Active
Anti-Gcdfp-15	AN856-5M	FDA UDI	Class I	Active
Anti-Collagen Iv	MU379-UC	FDA UDI	Class I	Active
Anti-Cd45 (lca)	MU338-UC	FDA UDI	Class I	Active
Anti-Cd4	NU722-5UC	FDA UDI	Class I	Active
Anti-Erg	AN782-10M	FDA UDI	Class I	Active
Anti-Cd68	AM416-10M	FDA UDI	Class I	Active
Anti-Lambda Light Chain	PU049-UP	FDA UDI	Class I	Active
Anti-Laminin	PU078-5UP	FDA UDI	Class I	Active
Anti-Cdx-2	AM392-10M	FDA UDI	Class I	Active
Anti-Cytokeratin Pan	MU357-UC	FDA UDI	Class I	Active
Anti-Cd79a	AN767-5M	FDA UDI	Class I	Active
Anti-Pcna	AM252-5M	FDA UDI	Class I	Active
Anti-Calretinin	AN747-5M	FDA UDI	Class I	Active
Anti-Cd71	AM354-5M	FDA UDI	Class I	Active
Anti-Melanoma Associated Antigen	MU077-UC	FDA UDI	Class I	Active
Anti-Msh2	AN743-5M	FDA UDI	Class I	Active
Anti-Erg	AN782-5M	FDA UDI	Class I	Active
Anti-Tle1	AMB58-5M	FDA UDI	Class I	Active
Anti-Cd138	AN837-5M	FDA UDI	Class I	Active
Anti-PR (Insite)	AM328-10M	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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.