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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-CD44	MU310-UC	FDA UDI	Class I	Active
Anti-Calponin-1	NU821-UC	FDA UDI	Class I	Active
Anti-Ki-67 Ag	MU297-UC	FDA UDI	Class I	Active
Anti-Glycophorin A	AMB36-5M	FDA UDI	Class I	Active
Conc Anti Human Cd4	NU722-UC	FDA UDI	Class I	Active
Anti-Bax Protein	AR347-5R	FDA UDI	Class I	Active
AEC (Aminoethylcarbazole)	HK092-5KE	FDA UDI	Class I	Active
Anti-Tle-1	MUB58-UC	FDA UDI	Class I	Active
Anti-Cytokeratin Lmw	MU075-UC	FDA UDI	Class I	Active
Caldesmon Hmw, Smooth Muscle	AM332-10M	FDA UDI	Class I	Active
Pepsin 4 Pack Kit	EK000-10K	FDA UDI	Class I	Active
AEC Substrate Pack	HK129-5KE	FDA UDI	Class I	Active
Anti-Gfap	AR020-10R	FDA UDI	Class I	Active
Anti-Wt1	AN940-10M	FDA UDI	Class I	Active
Anti-Cea	MU009-UC	FDA UDI	Class I	Active
Anti-P53 Protein	MU239-UC	FDA UDI	Class I	Active
Anti-Cyclin D1	AN815-5M	FDA UDI	Class I	Active
Cytokeratin 7	AM255-10M	FDA UDI	Class I	Active
Anti-Cd29	AM298-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 7	AM255-5M	FDA UDI	Class I	Active
Anti-Desmin	MU072-UC	FDA UDI	Class I	Active
Coverslips	XT121-YBX	FDA UDI	Class I	Active
Anti-Sox2	NU833-UC	FDA UDI	Class I	Active
Anti- Prolactin	MU031-UC	FDA UDI	Class I	Active
Anti-CA-IX	AMC19-5M	FDA UDI	Class I	Active
Anti-Melanoma-Associated Antigen	AX077-50D	FDA UDI	Class I	Active
Anti-ER	MU368-100	FDA UDI	Class II	Active
Anti-Gata-3	AMB43-5M	FDA UDI	Class I	Active
Anti-Hpv-16	AM362-5M	FDA UDI	Class I	Active
Anti-Cd79a	AN719-5M	FDA UDI	Class I	Active
Anti-Beta-Hcg	AM395-5M	FDA UDI	Class I	Active
Anti-Calcitonin	AN926-5M	FDA UDI	Class I	Active
Anti-Cd68	MU416-5UC	FDA UDI	Class I	Active
Anti-Melanoma	MU001A-UC	FDA UDI	Class I	Active
Anti-Cd16	AM437-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 6	AN845-5M	FDA UDI	Class I	Active
Anti-Vimentin	MU163-UC	FDA UDI	Class I	Active
Anti-CD23	AN988-5M	FDA UDI	Class I	Active
Anti- CD79A	NU719-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 20	AM315-10M	FDA UDI	Class I	Active
Anti-Cdx-2	MU392A-UC	FDA UDI	Class I	Active
Anti-Vegf	PU483-UP	FDA UDI	Class I	Active
Anti-Gfap	AR020-5R	FDA UDI	Class I	Active
Anti-Ca19-9	AM424-5M	FDA UDI	Class I	Active
Am310-5m	AM310-5M	FDA UDI	Class I	Active
Anti-SOX10	AM995-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 19	AX246-50D	FDA UDI	Class I	Active
Anti-Cytokeratin Pan	MU357-5UC	FDA UDI	Class I	Active
Anti-Muc1	NU813-5UC	FDA UDI	Class I	Active
Anti-Muc1	AN813-5M	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Notified Bodies

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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.