CAROLINA LIQUID CHEMISTRIES CORPORATION

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calibrator, multi-analyte mixture (JIX) (2) LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES (CDT) (1) LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE (CHI) (1) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (1) PHOTOMETRIC METHOD, MAGNESIUM (JGJ) (1) Phosphomolybdate (colorimetric), inorganic phosphorus (CEO) (1) Photometric method, iron (non-heme) (JIY) (1) Acid, uric, uricase (colorimetric) (KNK) (1) SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN (MRR) (1)

Premarket Exempt

No Yes

Clear

CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT DT212 - 00817302024418 Catalog Number : DT212

Device Description : Uric Acid (URIC) Reagent

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : KNK

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT DT213 - 00817302024425 Catalog Number : DT213

Device Description : Triglycerides (TRIG) Reagent

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : CDT

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT DT218 - 00817302024432 Catalog Number : DT218

Device Description : Phosphorus (PHOS) Reagent

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : CEO

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT DT220 - 00817302024449 Catalog Number : DT220

Device Description : Magnesium Arsenazo Reagent (MG)

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT DT240 - 00817302024456 Catalog Number : DT240

Device Description : Alanine Aminotransferase (ALT) (GPT) Reagent

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT DT618 - 00817302024463 Catalog Number : DT618

Device Description : Iron (Total) Reagent w/ Standard

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : JIY

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT DT621 - 00817302024470 Catalog Number : DT621

Device Description : Lipase Reagent (LIP) w/ Calibrator

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : CHI

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661 - 00817302024487 Catalog Number : DT661

Device Description : LDL Cholesterol Direct (LDLD) w/ Calibrator

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : MRR

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908 - 00817302024494 Catalog Number : DT908

Device Description : ISE CALIBRATOR 1

Device Class : 2

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909 - 00817302024500 Catalog Number : DT909

Device Description : ISE CALIBRATOR 2

Device Class : 2

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : Yes

Device Count : 1

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