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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-Cd15	AM302-10M	FDA UDI	Class I	Active
Anti-Melan-A	AM361-10M	FDA UDI	Class I	Active
Anti-P63	MU418-UC	FDA UDI	Class I	Active
Anti-Tia-1	AM529-5M	FDA UDI	Class I	Active
Anti-Cea	MU365-UC	FDA UDI	Class I	Active
Anti-Cd34	MU236-UC	FDA UDI	Class I	Active
Anti-Her2/Erbb2	AY726-YCD	FDA UDI	Class I	Active
Anti-Cd4	AM421-10M	FDA UDI	Class I	Active
Anti-Cea	AR009-5R	FDA UDI	Class I	Active
Anti-Luteinizing Hormone	NU787-UC	FDA UDI	Class I	Active
ANTI-vWF	AMA04-5M	FDA UDI	Class I	Active
Anti-Cmv	AM994-10M	FDA UDI	Class I	Active
Anti-Ki-67 Ag	AM297-5M	FDA UDI	Class I	Active
Anti-Tsh	MU033-UC	FDA UDI	Class I	Active
Anti-P504s/Amacr	NU538-UC	FDA UDI	Class I	Active
Anti-Stat6	AMB34-5M	FDA UDI	Class I	Active
Anti-ALK/CD246	MUB41-UC	FDA UDI	Class I	Active
Anti-Survivin	NU826-5UC	FDA UDI	Class I	Active
Anti-Cd21	NU745-UC	FDA UDI	Class I	Active
Anti-Pax5	MU967-UC	FDA UDI	Class I	Active
Anti-S100P	AM993-5M	FDA UDI	Class I	Active
Anti-S-100 Protein	AM058-10M	FDA UDI	Class I	Active
Anti- c-Myc	NUC25-UC	FDA UDI	Class I	Active
Anti-Ca125	AM429-5M	FDA UDI	Class I	Active
Pin 4 Cocktail	AM448-5M	FDA UDI	Class I	Active
Anti-C4d	ARA29-5R	FDA UDI	Class I	Active
i6000™ Infinity	AS6040	FDA UDI	Class I	Active
Anti-S100P	AM993-10M	FDA UDI	Class I	Active
Anti-PR (Insite)	MU328-5UC	FDA UDI	Class II	Active
Anti-C-myc-Protein	MU318-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 8 &18	MU131-UC	FDA UDI	Class I	Active
Anti-P16(ink4)	MU540-UC	FDA UDI	Class I	Active
Anti-OLIG2	ANC12-5M	FDA UDI	Class I	Active
Tris Wash Buffer	HK098-5K	FDA UDI	Class I	Active
Anti-Calponin	AM333-5M	FDA UDI	Class I	Active
Anti-P27	AM396-5M	FDA UDI	Class I	Active
Anti-Placental Lactogen	AR040-5R	FDA UDI	Class I	Active
Anti-Acth	MU487-5UC	FDA UDI	Class I	Active
Anti-Hif 2	ARB28-5R	FDA UDI	Class I	Active
Anti-CD163	MUA02-UC	FDA UDI	Class I	Active
H.pylori	AM880-10M	FDA UDI	Class I	Active
Anti-Caldesmon	AN774-5M	FDA UDI	Class I	Active
Avidin Biotin Blocking Kit	HK102-20X	FDA UDI	Class I	Active
Anti-P53 Protein	MU240-UC	FDA UDI	Class I	Active
Anti-Myeloperoxidase	AR496-10R	FDA UDI	Class I	Active
Anti-Cd5	AX430-YCD	FDA UDI	Class I	Active
Anti-C-Kit/Cd117	AN818-5M	FDA UDI	Class I	Active
Anti-Iga	PU045-5UP	FDA UDI	Class I	Active
Conc Anti Human Cd19	NU729-UC	FDA UDI	Class I	Active
Anti-Cd79a	MU414-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.