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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-Toxoplasma Gondii	PU125-5UP	FDA UDI	Class I	Active
Anti-Myf4	AM987-5M	FDA UDI	Class I	Active
Anti-Prolactin	MU978-5UC	FDA UDI	Class I	Active
Anti-Cd11b/Itam	NU851-UC	FDA UDI	Class I	Active
Anti-Cytokeratin	AM372-5M	FDA UDI	Class I	Active
Antis100	MUA15-UC	FDA UDI	Class I	Active
Anti-Cd3 (t-Cell)	AM322-10M	FDA UDI	Class I	Active
Anti-Thyroglobulin	MU032-UC	FDA UDI	Class I	Active
Anti-Cd20 (b Cell)	AM238-10M	FDA UDI	Class I	Active
Anti-Chromogranin A	AM356-5M	FDA UDI	Class I	Active
Anaplastic Lymphoma Kinase (alk)	AY874-50D	FDA UDI	Class I	Active
Anti-Vimentin	MU074-UC	FDA UDI	Class I	Active
Anti-Cd13	AN832-5M	FDA UDI	Class I	Active
Anti-Pten	AMB26-5M	FDA UDI	Class I	Active
Anti-Nkx3.1	MUA55-UC	FDA UDI	Class I	Active
Anti-E Cadherin	AN725-5M	FDA UDI	Class I	Active
Anti-P504s/Amacr	AY538-YCD	FDA UDI	Class I	Active
Anti-Cd45 (lca)	AM111-5MSG	FDA UDI	Class I	Active
Conc Anti Bcl-6	MU708-UC	FDA UDI	Class I	Active
Anti-Cd15	AX302-YCD	FDA UDI	Class I	Active
Anti-Cd45	AM941-5M	FDA UDI	Class I	Active
Anti-Vip	PU530-UP	FDA UDI	Class I	Active
Anti-S100P	MU993-UC	FDA UDI	Class I	Active
Anti-Alk/P80	AN770-5M	FDA UDI	Class I	Active
Anti-Cytokeratin Lmw	AM075-5M	FDA UDI	Class I	Active
Anti-C-Erbb-2 (her-2/Neu)	AM134-5M	FDA UDI	Class I	Active
Anti-Synaptophysin	AN857-5M	FDA UDI	Class I	Active
Anti-Cd22	MU962-5UC	FDA UDI	Class I	Active
Anti-Ki67	AM410-10M	FDA UDI	Class I	Active
Anti-Ema	AM057-5M	FDA UDI	Class I	Active
Melanoma	AM001-10M	FDA UDI	Class I	Active
Anti-Cd99	MU355-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 8 &18	AM131-10M	FDA UDI	Class I	Active
Anti-Cytokeratin Cocktail	AM071-10M	FDA UDI	Class I	Active
Anti-LAMBDA LIGHT CHAIN	NU715-UC	FDA UDI	Class I	Active
Anti-C-Kit/Cd117	AN818-5M	FDA UDI	Class I	Active
Anti-Synaptophysin	MU363-UC	FDA UDI	Class I	Active
Anti- Her2/Erbb2	NU726-UC	FDA UDI	Class I	Active
Anti-Estrogen Receptor-Alpha	NU710-UC	FDA UDI	Class I	Active
Anti-Pax-5	AM967-5M	FDA UDI	Class I	Active
Anti-Cd8	AN740-5M	FDA UDI	Class I	Active
Anti-Caldesmon	MU332-5UC	FDA UDI	Class I	Active
Anti-Ema	MU182-UC	FDA UDI	Class I	Active
Anti-Ki-67	MU370-UC	FDA UDI	Class I	Active
Anti-Muc4	MU455-UC	FDA UDI	Class I	Active
Anti-Pap	AM532-5M	FDA UDI	Class I	Active
Anti-Cdx2	MU392A-5UC	FDA UDI	Class I	Active
Anti-PR (Insite)	AM328-5MSG	FDA UDI	Class II	Active
Anti-Mesothelin	AM433-10M	FDA UDI	Class I	Active
Anti-Melan-A	AM361-10M	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.