Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021841051

FEI Number

3021841051

Entity Name

BIALEX LAB

City/State/Country

Wichita Falls, TX, US

Establishment Address

717 Ohio Ave, Wichita Falls, TX 76301, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bialex Lab (Owner Number: 10049801)

Owner / Operator Contact Address

717 Ohio Ave, Wichita Falls, TX 76301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042318

PMA Number

N/A

All Registered Proprietary Names

Bialex Uric Acid Bialex GGT Bialex Total Protein Bialex Cu Bialex ALT Bialex LDL Bialex CK Bialex Anti CCP Bialex Ammonia Bialex Phosphorus Bialex ?-HBDH UV Bialex THC Bialex LDH Bialex Triglycerides Bialex Amylase Bialex Dyazo Direct Bilirrubin Bialex Dyazo Total Bilirrubin Bialex Phosphatase Alkaline BIALEX FR Bialex Glucose Oxidase Bialex Triglycerides Bialex Ferric Chloride Test System Bialex Creatinine Bialex Total Protein BIALEX ASO Bialex Enzymatic Cholesterol Oxidase Bialex Direct HDL Bialex Precipitation HDL Bialex Emulsion Lipase Bialex Lipase KInetic Bialex Glucose Oxidase Bialex Albumin Bromcresol Bialex Amphetamine Bialex Kinetic Lipase Bialex Emulsion Lipase Bialex Acid phosphatase prostatic Bialex Na Bialex Cystine ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE Bialex Easy Lead-Check Bialex Creatinine Bialex PassCheck Multicontrol Bialex PassCheck Calibrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWW	Radioimmunoassay, Cholyglycine, Bile Acids	Clinical Chemistry	Class 2	862.1177	2025-01-27
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2016-10-27
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2016-01-26
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2022-04-06
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2026-04-06
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2022-04-06
JKZ	Diethyldithiocarbamate (Colorimetric), Copper	Clinical Chemistry	Class 1	862.1190	2024-02-08
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2016-01-26
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2016-01-26
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Clinical Chemistry	Class 1	862.1210	2023-09-17
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2022-03-03
JID	Photometric Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2015-09-14
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2023-01-27
JMK	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	Clinical Chemistry	Class 1	862.1380	2026-04-18
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2015-08-01
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2022-04-06
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2015-08-01
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2016-10-27
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2026-04-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2015-08-01
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2015-08-01
CJH	Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2015-09-14
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2022-03-03
NAQ	Lipoprotein, High Density, Hdl, Over The Counter	Clinical Chemistry	Class 1	862.1175	2015-09-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-09-14
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-09-14
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2015-09-14
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2015-09-14
NGO	Test, Triglycerides, Over The Counter	Clinical Chemistry	Class 1	862.1705	2015-09-14
JGK	Ferric Chloride, Phenylketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1560	2023-09-17
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-08-01
JIJ	Wet Ash Method, Protein-Bound Iodine	Clinical Chemistry	Class 1	862.1640	2023-09-17
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2022-04-06
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2015-08-01
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2026-04-06
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2022-04-06
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2022-04-06
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-08-01
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2023-01-27
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2022-04-06
CET	Olive Oil Emulsion (Turbidimetric), Lipase	Clinical Chemistry	Class 1	862.1465	2016-01-26
CKB	Acid Phosphatase, Naphthyl Phosphate	Clinical Chemistry	Class 2	862.1020	2026-04-18
MZU	System, Test, Sodium, Enzymatic Method	Clinical Chemistry	Class 2	862.1665	2015-08-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-08-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-08-01
JLC	Nitroprusside Reaction (Qualitative, Urine), Cystine	Clinical Chemistry	Class 1	862.1240	2023-01-27
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2011-05-31
JKL	Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry	Clinical Chemistry	Class 1	862.1060	2026-04-18
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-01-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-01-26

Official Correspondent

Carlos Quine

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bialex Lab

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K931362	Instrumentation Laboratory CO	IL TEST CALCIUM	1994-02-01
K830679	Dow Instruments & Reagents, Inc.	URIC ACID COLORIMETRIC DETERMINATION	1983-04-06
K861663	Data Medical Associates, Inc.	TOTAL PROTEIN PROCEDURE	1986-06-13
K832169	Sandare Chemical Co., Inc.	TOTAL PROTEIN PROCEDURE	1983-08-16
K771476	Instrumentation Laboratory CO	MULTISTAT III TOTAL PROTEIN TEST	1977-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2017	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Z-0006-2009	Roche Diagnostics Corp.	1	Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.
Z-0003-2007	N/A	2	Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
Z-0020-2014	Abbott Laboratories, Inc	1	Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021841051. Last updated year: 2026. Please use registration number 3021841051 when referencing this establishment in official correspondence.