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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
Address: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (756)

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Device	Model / Reference	Registries	Class	Status
Anti-C-Erbb-2 (her-2/Neu)	MU134-UC	FDA UDI	Class I	Active
Anti-Egfr	AN781-5M	FDA UDI	Class I	Active
Anti-Neurofilament	MU073-5UC	FDA UDI	Class I	Active
Anti-Cyclin D1	NU815-UC	FDA UDI	Class I	Active
Anti-Collagen Iv	AM379-5M	FDA UDI	Class I	Active
Anti-Cmv	AM254-5M	FDA UDI	Class I	Active
Anti-CD99	AY850-50D	FDA UDI	Class I	Active
Anti- HER2/ERBB2 PHOSPHO (PY877)	NU726-UC	FDA UDI	Class I	Active
Anti-Cytokeratin, Pan	AM181-5M	FDA UDI	Class I	Active
Anti-Ttf-1	AM397-5M	FDA UDI	Class I	Active
Anti-Caldesmon, HMW	MU332-UC	FDA UDI	Class I	Active
Anti-Ki-67 Ag	AM297-10M	FDA UDI	Class I	Active
Anti-Cd45ro (t-Cell)	AX113-YCD	FDA UDI	Class I	Active
Anti-Synaptophysin	MU363-5UC	FDA UDI	Class I	Active
Anti- c-Myc	ANC25-5M	FDA UDI	Class I	Active
Anti-Cd5	AN824-5M	FDA UDI	Class I	Active
Anti-Cd15	MU302-UC	FDA UDI	Class I	Active
Anti-Cytokeratin 19	AX246-YCD	FDA UDI	Class I	Active
Anti-Gfap	AN783-5M	FDA UDI	Class I	Active
Anti-Cd14	AN814-5M	FDA UDI	Class I	Active
Anti-Napsin A	AM701-5M	FDA UDI	Class I	Active
Anti-Calretinin	MU583-UC	FDA UDI	Class I	Active
Anti-Bcl-2 Oncoprotein	AM287-5M	FDA UDI	Class I	Active
Anti-ER (Insite)	AX368-50D	FDA UDI	Class II	Active
Anti-Calponin-1	AN821-5M	FDA UDI	Class I	Active
Anti-Alk	NU874-UC	FDA UDI	Class I	Active
Anti-P504s	AN449-10M	FDA UDI	Class I	Active
Anti-P27/Kip1	AN817-5M	FDA UDI	Class I	Active
Anti-Atrx	AMB05-5M	FDA UDI	Class I	Active
Anti-CA19-9	MU424-UC	FDA UDI	Class I	Active
Cd79a [sp18] For Xmatrx	AY767-YCD	FDA UDI	Class I	Active
Anti-Gcdfp-15	MU953-UC	FDA UDI	Class I	Active
Protease Xxiv 4-Pack Kit	EK002-10K	FDA UDI	Class I	Active
Anti-Lysozyme	AR024-5R	FDA UDI	Class I	Active
Anti-P53 Protein	MU239-5UC	FDA UDI	Class I	Active
Anti-ER (Insite)	MU368-UC	FDA UDI	Class II	Active
Anti-Cytokeratin 14	AM146-5M	FDA UDI	Class I	Active
Ki-67 Ag	FG-297M	FDA UDI	Class I	Active
Anti-Gfap	AX020-YCD	FDA UDI	Class I	Active
ANTI-KI-67 Antigen	AX297-YCD	FDA UDI	Class I	Active
Anti-Factor XIIIa	AM337-5M	FDA UDI	Class I	Active
Anti-Gcdfp-15	NU856-UC	FDA UDI	Class I	Active
2-Compnent DAB Pack	HK542-XAKE	FDA UDI	Class I	Active
Riagen B-Hcg Ria	K821234	FDA 510(k)	Class II	Active
Biogenex Monoclonal Anti-Progesterone Receptor	K012960	FDA 510(k)	Class II	Active
Pregnagen(tm)	K884880	FDA 510(k)	Class II	Active
Fluorogen Pap Fia	K820724	FDA 510(k)	Class II	Active
Pregnagen(tm)	K882002	FDA 510(k)	Class II	Active
Modified Ovugen	K902208	FDA 510(k)	Class I	Active
Riagen Pap Ria	K813261	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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.