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Carolina Liquid Chemistries Corp.

Last updated September 17, 2026

What Carolina Liquid Chemistries Corp. makes

Carolina Liquid Chemistries Corp. manufactures in vitro diagnostics (IVDs) for clinical chemistry and drug testing, including enzyme immunoassay (EIA) kits for substances like 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), opiates, benzodiazepines, and buprenorphine. Their portfolio also covers reagent kits for analytes such as alanine aminotransferase (ALT), alkaline phosphatase (ALP), and direct HDL cholesterol assays, alongside automated/semi-automated system calibrators and wash solutions. Rapid immunoassay test kits for clinical use, such as those for oxycodone detection, are also part of their offerings. The company produces analyzer systems and immunofluorescence-based diagnostic tools for laboratory applications.

The company’s IVDs are regulated under FDA’s 510(k) clearance process for Class II devices, with some products classified as Class I or unclassified (U). Devices are listed in the FDA’s Unique Device Identifier (UDI) database. Carolina Liquid Chemistries Corp. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 510 W Central Ave Ste C, Brea, CA, 92821
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3000215862
DUNS Number: —

Catalogue (361)

Page 1 of 8

Device	Model / Reference	Registries	Class	Status
CLC6410 Chemistry Analyzer with or without ISE	CLC6410	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Alanine Aminotransferase Reagent Kit Dt240	DT240	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Eddp Rgt. Kit St426	ST426	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Alp Rgt.kit Bl-206	BL206	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200	28200	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Hdl Direct Cc615	CC615	FDA UDI	Class I	Active
CAROLINA LIQUID CHEMISTRIES CORP.® EDDP REAGENT KIT Product No. DT426	DT426	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.™ Dbil Direct Bilirubin Reagent Cc229	CC229	FDA UDI	Class II	Unknown
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 TBIL RGT KIT Product No. ST228	ST228	FDA UDI	Class II	Active
Carolina Liquid Chemistries CRPhsWR	AU-645B	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT KIT Product No. DT415	DT415	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Barb Barbiturate Cc417	CC417	FDA UDI	Class II	Unknown
Carolina Liquid Chemistries Corp.® Prox Rgt. Kit St416	ST416	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN	CLCE1106	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Creatinine Check Reagent Kit Cc448	CC448	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Pcp Rgt. Kit Au-414	AU-414	FDA UDI	U	Active
Carolina Liquid Chemistries Corp.® Prox Rgt. Kit Bl-416	BL416	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Alb Rgt.kit Bl-224	BL-224.	FDA UDI	Class II	Active
Carolina Liquid Chemistries CRPhsWR	BL-645B	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT Product No. DT427	DT427	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Glu Rgt. Kit Au-208	AU-208	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Eddp Rgt. Kit Bl-426	BL426	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Op Rgt. Kit Au-411a	AU-411A	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Meth Rgt. Kit Bl-427	BL427	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Pcp Rgt. Kit St414	ST414	FDA UDI	U	Active
Carolina Liquid Chemistries Corp.® 6-Am Rgt. Kit Mr425	MR425	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Lipase Reagent Kit Dt621	DT621	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Alb Rgt.kit Au-214	AU-214	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Eddp Rgt. Kit St326	ST326	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Oxycodone Cc419b	CC419B	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Wash Solution Au-2000	AU-2000	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Uric Acid Reagent Kit Au-212	AU-212	FDA UDI	Class I	Active
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 BUN REAGENT KIT Product No. ST252	ST252	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Amy Reagent Product No. Dt227	DT227	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT KIT Product No. DT413	DT413	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Alanine Aminotransferase Reagent Kit Cc240	CC240	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Ldl Direct Reagent Cc667	CC667	FDA UDI	Class I	Unknown
Carolina Liquid Chemistries Corp.® Meth Rgt. Kit Au-427	AU-427	FDA UDI	Class I	Unknown
Carolina Liquid Chemistries Corp.® Amph Rgt. Kit St312	ST312	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Prox Rgt. Kit St316	ST316	FDA UDI	Class II	Unknown
Carolina Liquid Chemistries Corp.® Glu Glucose Reagent Cc208	CC208	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® BUP REAGENT KIT Product No. DT424	DT424	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Uibc Unsaturated Iron Binding Capacity Cc660	CC660	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Triglycerides Reagent Kit Au-213	AU-213	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.™ Calcium Reagent 88815	88815	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.™ Amy Amylase Reagent Cc227	CC227	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Triglycerides Reagent Kit St213	ST213	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Ast Reagent Product No. Dt241	DT241	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Magnesium Reagent Kit St220	ST220	FDA UDI	Class I	Active
Caldon Biotech Serum Aldolase Controls	COAL-015	FDA UDI	Class I	Active

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Carolina Liquid Chemistries Corp. has four FDA recall records initiated between January 16, 2019, and February 10, 2020, all of which are marked as terminated. The reasons cited include mislabeling for diagnostic use without FDA clearance, deviations in product performance (specifically absorbance rate in the Ethyl Alcohol Assay), and corrections to labeling to clarify intended use for forensic or research purposes only.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 10, 2020	Z-1701-2020	—	terminated	Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.
Jan 20, 2020	Z-1743-2020	—	terminated	Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes
Jan 16, 2019	Z-1253-2019	—	terminated	Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
Jan 16, 2019	Z-1252-2019	—	terminated	—