Data / Medical devices / United States / Biogenex Laboratories Inc.

Biogenex Laboratories Inc.: FDA-registered device maker in Fremont, CA, United States, 2 510(k) clearances

Name: Biogenex Laboratories Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biogenex Laboratories Inc. is registered with the FDA (registration 3008776165) in Fremont, CA, United States. It lists 36 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 8, 2002. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Biogenex Laboratories Inc.

FDA registration number: 3008776165
FEI number: 2936532
Address: 48810 Kato Road,Suite 100E&200E, Fremont, CA, United States, 94538
Owner or operator: BIOGENEX LABORATORIES INC. (2936532)
Roles: Manufacturer
First device listed: September 23, 1994
Registered through: 2026
Brand names listed: 2-Component DAB Pack, ABL1 PROBE, AEC CHROMOGEN, AEC SUBSTRATE KIT, CONC, AEC SUBSTRATE PACK KIT, AEC Substrate, AFB Green Kit, ALIZARIN RED STAIN and more

Devices it lists

Device	Product code	Class	Role	Source
Alcian Blue	IDA	1	Manufacturer	accessdata.fda.gov
Azure A	ICQ	1	Manufacturer	accessdata.fda.gov
Carbol Fuchsin	ICL	1	Manufacturer	accessdata.fda.gov
Congo Red	ICH	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Formulations, Paraffin, All	KEO	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Giemsa Stain	HYF	1	Manufacturer	accessdata.fda.gov
Hematoxylin	HYJ	1	Manufacturer	accessdata.fda.gov
Hematoxylin Mayer'S	HYL	1	Manufacturer	accessdata.fda.gov
Immunohistochemistry Antibody Assay, Estrogen Receptor	MYA	2	Manufacturer	accessdata.fda.gov
Immunohistochemistry Assay, Antibody, Progesterone Receptor	MXZ	2	Manufacturer	accessdata.fda.gov
Immunohistochemistry Reagents And Kits	NJT	1	Manufacturer	accessdata.fda.gov
Iron Stains	GGH	1	Manufacturer	accessdata.fda.gov
Methenamine Silver	HYZ	1	Manufacturer	accessdata.fda.gov
Methyl Green	HZA	1	Manufacturer	accessdata.fda.gov
Mucicarmine	HZC	1	Manufacturer	accessdata.fda.gov
Nuclear Fast Red	HZF	1	Manufacturer	accessdata.fda.gov
Oil Red O	HZG	1	Manufacturer	accessdata.fda.gov
Ph Buffer	JCC	1	Manufacturer	accessdata.fda.gov
Processor, Tissue, Automated	IEO	1	Manufacturer	accessdata.fda.gov
Reagent, Schiff	HZT	1	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
Safranin	HZS	1	Manufacturer	accessdata.fda.gov
Silver Nitrate	HZX	1	Manufacturer	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Manufacturer	accessdata.fda.gov
Slides, Microscope	KEW	1	Manufacturer	accessdata.fda.gov
Solution, Silver Carbonate	KKP	1	Manufacturer	accessdata.fda.gov
Stain, Papanicolau	HZJ	1	Manufacturer	accessdata.fda.gov
Stain, Trichrome, Mallory'S	HYW	1	Manufacturer	accessdata.fda.gov
Stainer, Tissue, Automated	KEY	1	Manufacturer	accessdata.fda.gov
Stains, Dye Solution	LEE	1	Manufacturer	accessdata.fda.gov
Stains, Microbiologic	JTS	1	Manufacturer	accessdata.fda.gov
Sudan Black B	HZZ	1	Manufacturer	accessdata.fda.gov
Toluidine Blue	IAB	1	Manufacturer	accessdata.fda.gov
Trypsin	IBG	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 8, 2002	K012960	BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR	MXZ	Substantially Equivalent	Biogenex Laboratories	accessdata.fda.gov
February 28, 2002	K013148	BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)	MYA	Substantially Equivalent	Biogenex Laboratories	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 1, 2014	68709	Class II	Terminated	InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.	Product was distributed without 510(k) approval.	accessdata.fda.gov
January 23, 2009	51296	Not yet classified	Terminated	Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and	Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution.	accessdata.fda.gov
January 24, 2008	46903	Not yet classified	Terminated	Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B	Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.	accessdata.fda.gov
October 3, 2006	36514	Not yet classified	Terminated	Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.	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.	accessdata.fda.gov
September 5, 2006	36259	Not yet classified	Terminated	Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M, manufactured and distributed by BioGenex, San Ramon, CA	Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.	accessdata.fda.gov
June 2, 2006	35614	Not yet classified	Terminated	BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583	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).	accessdata.fda.gov
February 9, 2006	34586	Not yet classified	Terminated	Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; Model Numbers: RD134-60K; Lot Numbers: RD1340205, RD1340205X, RD1	Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.	accessdata.fda.gov

Compare with other makers

Updated July 24, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.