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Carolina Liquid Chemistries Corp.

Last updated September 17, 2026

Information

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

Catalogue (361)

Page 7 of 8

Device	Model / Reference	Registries	Class	Status
CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit	BL-204B	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Xtsy Rgt. Kit Mr423	MR423	FDA UDI	Class I	Unknown
CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT Product No. ST201	ST201	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Cholesterol Reagent Kit Dt211	DT211	FDA UDI	Class I	Active
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300	CC300	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Barb Rgt. Kit Mr417	MR417	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Cyst Cystatin Cc691	CC691	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Ldl Cholesterol Direct Reagent Kit Bl661	BL661	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Hdld Rgt. Kit Au-616	AU-616	FDA UDI	Class I	Active
Carolina Liquid Chemistries Methadone Metabolite EDDP	AU-426B	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Oxyc Rgt. Kit Au-419b	AU-419B	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Iron Reagent Kit Au-618	AU-618	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Metd Rgt. Kit Au-415	AU-415	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Co2 Reagent Product No. Dt313	DT313	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® OP RGT KIT Product No. DT415	DT411	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Thc50 Rgt. Kit St410a	ST410A	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Prox Rgt. Kit Mr416	MR416	FDA UDI	Class II	Unknown
Carolina Liquid Chemistries Corp.® Crp-W Wide Range Cc645	CC645	FDA UDI	Class II	Unknown
Carolina Liquid Chemistries Corp.® Rf Reagent Cc629	CC629	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Op Rgt. Kit St311a	ST311A	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT KIT Product No. DT417	DT417	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Barb Rgt. Kit St317	ST317	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® TBENZ RGT KIT Product No. ST441	ST441	FDA UDI	Class II	Active
Carolina Liquid Chemistries CRPhsWR	ST645B	FDA UDI	Class II	Active
CLC1600 Chemistry Analyzer with ISE Module	CLC1600	FDA UDI	Class II	Active
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 LDH RGT KIT Product No. ST205	ST205	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Fruc Rgt. Kit Au-612	AU-612	FDA UDI	Class II	Unknown
CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT KIT Product No. DT418	DT418	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Clc720 Creatinine Reagent Kit	ST243	FDA UDI	Class II	Active
Carolina Liquid Chemistries Methadone Metabolite EDDP	ST326B	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Ggt Reagent Kit St209	ST209	FDA UDI	Class I	Active
Synchron Cx® Total Protein Reagent Kit 88816	88816	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Amph Rgt. Kit Bl-412	BL412	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Tp Rgt. Kit Bl-217	BL217	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Ca Rgt. Kit Bl-251	BL251	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Ldl Cholesterol Direct Reagent Kit Dt661	DT661	FDA UDI	Class I	Active
Carolina Liquid Chemistries Corp.® Cocm Rgt. Kit St413	ST413	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Metd Rgt. Kit St315	ST315	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Barb Rgt. Kit Bl-417	BL417	FDA UDI	Class II	Active
Carolina Liquid Chemistries Corp.® Ldh Rgt. Kit Bl-205	BL205	FDA UDI	Class II	Active
Total Protein Or Tp	K971524	FDA 510(k)	Class II	Active
Synchron Cx Systems Gamma-Glutamyl Transferase Reagent (ggt)	K971466	FDA 510(k)	Class I	Active
Alb Or Albumin	K971445	FDA 510(k)	Class II	Active
Ast Or Sgot	K971344	FDA 510(k)	Class II	Active
Calcium Reagent	K971907	FDA 510(k)	Class II	Active
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System	K213211	FDA 510(k)	Class II	Active
Alp Reagent Set	K971463	FDA 510(k)	Class II	Active
Alt Or Sgpt	K971323	FDA 510(k)	Class I	Active
Synchron Cx Systems Glucose Reagent (glu)	K971467	FDA 510(k)	Class II	Active
Ld-L Reagent	K971398	FDA 510(k)	Class II	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.

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	—