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Carolina Liquid Chemistries Corp.

US

Last updated September 17, 2026

Information

Country
US
Address
510 W Central Ave Ste C, Brea, CA, 92821
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3000215862
DUNS Number
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Catalogue (361)

Page 6 of 8
DeviceModel / ReferenceRegistriesClassStatus
Carolina Liquid Chemistries Corp.® Prox Propoxyphene Cc416 CC416
FDA UDI
Class IIUnknown
Carolina Liquid Chemistries Corp.® Etha Rgt. Kit Au-421 AU-421
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Apob Rgt. Kit Au-633 AU-633
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Cocm Cocaine Cc413 CC413
FDA UDI
Class IUnknown
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL 7-H7541-CAL
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Tbil Rgt. Kit Bl-228 BL228
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Pcp Phencyclidine Cc414 CC414
FDA UDI
UUnknown
CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit AU-204B
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Metd Rgt. Kit Mr415 MR415
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Amy Rgt. Kit Au-227 AU-227
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Triglycerides Reagent Kit Cc213 CC213
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Crp-W Control Set Cc049 CC049
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Hcy Level 3 Control Kit Part# Cc053 CC053
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Thc50 Rgt. Kit Mr410a MR410A
FDA UDI
Class IIActive
CAROLINA LIQUID CHEMISTRIES CORP.® DBIL RGT. KIT Product No. AU-229 AU-229
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.™ Bun Reagent 88806 88806
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Cholesterol Reagent Kit St211 ST211
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Ise Selectivity Check Dt910 DT910
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Cholesterol Reagent Kit Au-211 AU-211
FDA UDI
Class IActive
CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200 28200
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Phosphorus Reagent Kit Dt218 DT218
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Ethyl Alcohol Cc421 CC421
FDA UDI
Class IIUnknown
Carolina Liquid Chemistries Corp.® Oxyc Rgt. Kit Mr419b MR419B
FDA UDI
Class IActive
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CA RGT KIT Product No. ST251 ST251
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Ggt Reagent Kit Cc209 CC209
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Bun Urea Nitrogen Reagent Cc252 CC252
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.™ Alb Albumin Reagent Cc214 CC214
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Xtsy Rgt. Kit St423 ST423
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Amph Rgt. Kit Au-412 AU-412
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Wash Solution Au-160 AU-160
FDA UDI
Class IActive
CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200 28200
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Crea Reagent Product No. Dt243 DT243
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Etha Rgt. Kit St321 ST321
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Crpw Rgt. Kit Bl-645 BL645
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Xtsy Rgt. Kit Bl-423 BL423
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Thc50 Rgt. Kit St310a ST310A
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Hydro Rgt. Kit St342 ST342
FDA UDI
Class IIUnknown
Carolina Liquid Chemistries Corp.® Pcp Rgt. Kit St314 ST314
FDA UDI
UActive
CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT KIT Product No. DT412 DT412
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Wash Concentrate Kit 88805 88805
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Alp Reagent Product No. Dt206 DT206
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Crpw Rgt. Kit Au-645 AU-645
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® 6-Am Rgt. Kit Au-425 AU-425
FDA UDI
Class IActive
Ise Electrolyte Reference 88811 88811
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Ca Reagent Product No. Dt251 DT251
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.™ Tbil Total Bilirubin Reagent Cc228 CC228
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Phosphorus Reagent Kit Cc218 CC218
FDA UDI
Class IActive
Carolina Liquid Chemistries Corp.® Prox Rgt. Kit Au-416 AU-416
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Meth Rgt. Kit St427 ST427
FDA UDI
Class IIActive
Carolina Liquid Chemistries Corp.® Ise Calibrator 2 Dt909 DT909
FDA UDI
Class IIActive

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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.

DateRecall No.ClassStatusReason
Feb 10, 2020Z-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, 2020Z-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, 2019Z-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, 2019Z-1252-2019—terminated

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