FDA Registration
Active
🇺🇸 United States
Carolina Liquid Chemistries Corp.
Reg #: 2030861
·
FEI: 3000215862
·
Expires 2026
Products
67
Proprietary Names
11
Establishment Types
4
Classifications
67
Registration Details
- Registration Name
- Carolina Liquid Chemistries Corp.
- Registration Number
- 2030861
- FEI Number
- 3000215862
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 510 W Central Ave Ste C
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110298
Owner / Operator
- Firm Name
- Corporate Headquarters, Carolina Liquid Chemistries, Corp.
- Operator Number
- 9028676
- Address
- 313 Gallimore Dairy Road
- City
- Greensboro
- State
- NC
- Postal Code
- 27409
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2011-12-01 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 2011-12-01 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2011-12-06 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2011-12-13 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2011-12-13 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2006-06-20 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2006-06-20 |
| Alcohol Control Materials | DKC | Class 1 | Clinical Toxicology | No | 2011-12-01 |
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2011-12-01 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2011-12-01 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2011-12-01 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2011-12-01 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2021-09-08 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2011-12-06 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2011-12-08 |
| Detergent | JCB | Class 1 | Pathology | No | 2011-12-05 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2013-07-08 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2011-12-01 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2011-12-01 |
| Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase | CJC | Class 1 | Clinical Chemistry | No | 2019-12-11 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2011-12-13 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2006-06-20 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2011-12-06 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2011-12-06 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2011-12-01 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2006-06-20 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2015-12-18 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2023-02-23 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2014-05-30 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2011-12-08 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2015-12-18 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2006-06-20 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2011-12-09 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2011-12-08 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2014-05-23 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2017-10-13 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2014-05-30 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2014-05-30 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2014-05-30 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-05-30 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2014-05-30 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2014-05-30 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2006-06-20 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2015-12-17 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2015-06-19 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2011-12-01 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2014-05-30 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2015-12-17 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2011-12-06 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2011-12-08 |
| Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | DMT | Class 2 | Clinical Toxicology | No | 2015-12-17 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | Class 1 | Clinical Chemistry | No | 2006-06-20 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2011-12-05 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2018-08-21 |
| Ph Meter | JQY | Class 1 | Clinical Chemistry | No | 2022-08-16 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2011-12-01 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2006-06-20 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2011-12-01 |
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
Carolina Liquid Chemistries Corp.
pH Reagent
Carolina Liquid Chemistries CRPhsWR
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)