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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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Catalogue (756)

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Device	Model / Reference	Registries	Class	Status
Anti-Cd79a	MU414-5UC	FDA UDI	Class I	Active
Anti-Herpes Simplex Virus Type I	PU084-5UP	FDA UDI	Class I	Active
Anti-Cd3 (t-Cell)	AM322-5M	FDA UDI	Class I	Active
H.pylori	AY880-YCD	FDA UDI	Class I	Active
Anti-P53 Protein	MU195-5UC	FDA UDI	Class I	Active
Anti-Ki67	MU410-5UC	FDA UDI	Class I	Active
Anti-Vimentin	MU074-5UC	FDA UDI	Class I	Active
Anti-Ttf1	NU887-UC	FDA UDI	Class I	Active
Anti-Atrx	MUB05-5UC	FDA UDI	Class I	Active
Anti-Afp	MU008A-UC	FDA UDI	Class I	Active
Anti-Oct-2	NU830-5UC	FDA UDI	Class I	Active
Anti-Cd34	NU779-UC	FDA UDI	Class I	Active
Anti-Melanoma	MU001A-5UC	FDA UDI	Class I	Active
Anti-Ttf1	AY887-YCD	FDA UDI	Class I	Active
Anti-Cd 7	MU702-UC	FDA UDI	Class I	Active
Anti-Actin	MU128-5UC	FDA UDI	Class I	Active
Anti-Kappa Light Chain	MU980-5UC	FDA UDI	Class I	Active
Anti-Cd38	AN769-5M	FDA UDI	Class I	Active
Anti-Calretinin	AM583-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 7	AX255-50D	FDA UDI	Class I	Active
Anti-Smoothelin	AMB40-5M	FDA UDI	Class I	Active
Anti-Ep-Cam	AN820-10M	FDA UDI	Class I	Active
Anti-Cd3 (t-Cell)	MU322-UC	FDA UDI	Class I	Active
Anti-Thyroglobulin	MU032-5UC	FDA UDI	Class I	Active
Anti-SV40 T Ag	AMB74-5M	FDA UDI	Class I	Active
Anti-Pms2	AN844-5M	FDA UDI	Class I	Active
Anti-Melanoma	AM001-10M	FDA UDI	Class I	Active
Anti-Cd43	AN748-5M	FDA UDI	Class I	Active
Anti-Androgen Receptor	AM256-10M	FDA UDI	Class I	Active
Anti-Desmin	AX072-YCD	FDA UDI	Class I	Active
Anti-Cd5	NU824-UC	FDA UDI	Class I	Active
Diluent	HK156-5K	FDA UDI	Class I	Active
Anti-Acth	AM487-5M	FDA UDI	Class I	Active
Anti-Egfr	AN781-10M	FDA UDI	Class I	Active
Anti-Wilm's Tumor	AN940-5M	FDA UDI	Class I	Active
Anti-Cytokeratin 18	AM143-5M	FDA UDI	Class I	Active
Anti-Cea	AM365-5M	FDA UDI	Class I	Active
Anti-Cd15	AM302-5M	FDA UDI	Class I	Active
Anti-Tdt	NU881-UC	FDA UDI	Class I	Active
Anti-PR (Insite)	AX328-YCD	FDA UDI	Class II	Active
Anti-S100	AMA15-5M	FDA UDI	Class I	Active
Hpv 14 Probe	PR251-YAD	FDA UDI	Class I	Active
Anti-Cea	MU009-5UC	FDA UDI	Class I	Active
Anti-Survivin	AN826-5M	FDA UDI	Class I	Active
Anti- Sarcomeric Actin	AM511-5M	FDA UDI	Class I	Active
Anti-Hsv I	PU084-UP	FDA UDI	Class I	Active
Anti-P63	AM418-10M	FDA UDI	Class I	Active
Anti-Cd45 (lca)	AX111-50D	FDA UDI	Class I	Active
Anti-Cd79a	NU719-5UC	FDA UDI	Class I	Active
Anti-VIMENTIN	AM163-10M	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.