Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030861

FEI Number

3000215862

Entity Name

Carolina Liquid Chemistries Corp.

City/State/Country

Brea, CA, US

Establishment Address

510 W Central Ave Ste C, Brea, CA 92821, US

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Corporate Headquarters, Carolina Liquid Chemistries, Corp. (Owner Number: 9028676)

Owner / Operator Contact Address

313 Gallimore Dairy Road, Greensboro, NC 27409, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K971309

PMA Number

N/A

All Registered Proprietary Names

C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET Aldolase Controls RYAN Carolina Liquid Chemistries Corp., Immunofluorescence Analyzer RYAN Carolina Liquid Chemistries STD Iron Standard Carolina Liquid Chemistries Corp. Fentanyl Urine Detection Kit, Carolina Liquid Chemistries Corp. Immunofluorescence analyzer RYAN CLC Basic Multi-Drug Control Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2011-12-01
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2011-12-01
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2011-12-06
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2011-12-13
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-12-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-06-20
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2006-06-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-17
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2011-12-01
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2011-12-01
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2011-12-01
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2011-12-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-12-01
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2021-09-08
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2011-12-06
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-12-17
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2011-12-08
JCB	Detergent	Pathology	Class 1	864.4010	2011-12-05
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-07-08
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2011-12-01
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2011-12-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-12-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2022-10-25
CJC	Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase	Clinical Chemistry	Class 1	862.1040	2019-12-11
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2011-12-13
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2006-06-20
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2011-12-06
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-12-06
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-07-08
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2011-12-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-12-01
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-12-01
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2011-12-01
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2006-06-20
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2011-12-01
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2015-12-18
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-18
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-18
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-12-26
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2014-12-26
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2014-12-26
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-17
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-17
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-12-17
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-02-23
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2014-05-30
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2014-05-30
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2014-05-30
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2011-12-08
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-12-18
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2015-12-17
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2006-06-20
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-12-09
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2022-08-16
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-12-08
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2014-05-23
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Hematology	Class 1	864.9320	2017-10-13
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2006-06-20
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2023-02-23
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-02-23
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2011-12-01
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-05-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-05-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-05-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-05-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-05-30
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-05-30
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2006-06-20
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-06-10
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-12-01
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2011-12-01
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-12-01
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-12-17
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2015-06-19
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2015-06-19
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2015-06-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-06-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2015-06-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-18
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-18
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-18
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-08-18
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2011-12-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-07-11
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-07-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2014-05-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-07-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-07-11
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2013-07-11
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-06-13
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-06-13
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2011-12-01
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2011-12-01
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2011-12-01
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2011-12-01
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2011-12-01
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-12-17
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2011-12-06
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-01-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-12-17
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-12-17
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-12-17
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2011-12-08
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2006-07-25
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2015-12-17
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2014-06-03
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-06-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2014-06-03
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2023-02-23
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	1996-11-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2020-04-02
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2011-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corporate Headquarters, Carolina Liquid Chemistries, Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009880320	Carolina Liquid Chemistries	Greensboro, NC, US

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Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030861. Last updated year: 2026. Please use registration number 2030861 when referencing this establishment in official correspondence.