Data / Medical devices / United States / Bialex Lab

Bialex Lab: FDA-registered device maker in Wichita Falls, TX, United States, 18 510(k) clearances

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

Bialex Lab is registered with the FDA (registration 3021841051) in Wichita Falls, TX, United States. It lists 49 device types. The FDA files 18 510(k) clearances under its listings, the newest dated May 15, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021841051
Address: 717 Ohio Ave, Wichita Falls, TX, United States, 76301
Owner or operator: Bialex Lab (10049801)
Roles: Manufacturer, Manufacturer for export
First device listed: May 31, 2011
Registered through: 2026
Brand names listed: BIALEX ACID PHOSPHATASE, BIALEX ALBUMIN BROMCRESOL, BIALEX ALT, BIALEX AMYLASE, BIALEX ANTI B2 MG, BIALEX ANTI B2 MICROGLOBULIN, BIALEX ASO, BIALEX AST and more

Devices it lists

Device	Product code	Class	Role	Source
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase	DLI	1	Manufacturer	accessdata.fda.gov
Acid Phosphatase, Naphthyl Phosphate	CKB	2	Manufacturer	accessdata.fda.gov
Acid Phosphatase, Thymol Blue Monophosphate	CJR	2	Manufacturer	accessdata.fda.gov
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	JMK	1	Manufacturer	accessdata.fda.gov
Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry	JKL	1	Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry, Centrifugal, For Clinical Use	JJG	1	Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Manufacturer	accessdata.fda.gov
Atomic Absorption, Lithium	JII	2	Manufacturer	accessdata.fda.gov
Atp And Creatine Kinase (Enzymatic), Creatine	JLB	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Beta-2-Glycoprotein I, Antigen, Antiserum, Control	DDN	1	Manufacturer for export	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Bromcresol Purple Dye-Binding, Albumin	CJW	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Manufacturer for export	accessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl Transpeptidase	JPZ	1	Manufacturer for export	accessdata.fda.gov
Colorimetric Method, Triglycerides	JGY	1	Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Diethyldithiocarbamate (Colorimetric), Copper	JKZ	1	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Ferric Chloride, Phenylketones (Urinary, Non-Quant.)	JGK	1	Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Kit, Identification, Mycobacteria	JSY	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Manufacturer	accessdata.fda.gov
Lowry (Colorimetric), Total Protein	JGP	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid	JLZ	1	Manufacturer	accessdata.fda.gov
Ninhydrin, Nitrogen (Amino-Nitrogen)	JMX	1	Manufacturer	accessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), Lipase	CET	1	Manufacturer	accessdata.fda.gov
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes	CKF	2	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Saccharogenic, Amylase	CIJ	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
Streptolysin O	IBA	1	Manufacturer	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Manufacturer	accessdata.fda.gov
System, Test, Sodium, Enzymatic Method	MZU	2	Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer for export	accessdata.fda.gov
Test, System, Potassium, Enzymatic Method	MZV	2	Manufacturer	accessdata.fda.gov
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase	CFH	2	Manufacturer	accessdata.fda.gov
Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes	CJH	2	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
May 15, 2013	K123586	EASYRA CREATININE REAGENT	CGX	Substantially Equivalent	Medica Corporation	accessdata.fda.gov
December 5, 2008	K082001	DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B	JII	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
June 26, 2008	K072142	S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST	CKF	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.	accessdata.fda.gov
December 9, 2004	K042318	AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET	JJY	Substantially Equivalent	Aalto Scientific, Ltd.	accessdata.fda.gov
October 29, 2004	K042191	DIAZYME POTASSIUM ENZYMATIC ASSAY KIT	MZV	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
October 7, 2004	K042189	DIAZYME SODIUM ENZYMATIC ASSAY	MZU	Substantially Equivalent	Diazyme Laboratories	accessdata.fda.gov
December 9, 2002	K023550	WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA	KNK	Substantially Equivalent	Wiener Laboratories Saic	accessdata.fda.gov
July 17, 2002	K021636	ALBUMIN REAGENT	CJW	Substantially Equivalent	Intersect Systems, Inc.	accessdata.fda.gov
August 5, 1999	K992002	AUTOHDL CHOLESTEROL REAGENT SET	LBR	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
April 21, 1997	K971005	TRIGLYCERIDES	JGY	Substantially Equivalent	Derma Media Lab., Inc.	accessdata.fda.gov
July 27, 1993	K931888	TOTAL BILIRUBIN	CIG	Substantially Equivalent	Em Diagnostic Systems, Inc.	accessdata.fda.gov
June 29, 1993	K930679	DIRECT BILIRUBIN	CIG	Substantially Equivalent	Horizon Diagnostics, Inc.	accessdata.fda.gov
April 22, 1987	K870928	CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS	CHH	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
January 14, 1986	K855194	GLUCOSE OXIDASE REAGENT SET	CGA	Substantially Equivalent	Technostics Intl.	accessdata.fda.gov
December 31, 1981	K813495	ALT (SGPT)	CKA	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
December 22, 1981	K813405	AST(SGOT) IN VITRO DIAG. REAGENT SET	CIT	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
October 20, 1981	K812794	LIPASE	CET	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
January 29, 1980	K792551	ALKALINE PHOSPHATASE REAGENT	CJH	Substantially Equivalent	Electrophoresis Corp. of America	accessdata.fda.gov

Compare with other makers

Updated May 15, 2013. 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.