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

Drug mixture control materials (DIF) (1) LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE (CHI) (1) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (1) SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN (MRR) (1)

Premarket Exempt

No Yes

Clear

CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621 - 00817302024616 Catalog Number : ST621

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 ST661 - 00817302024623 Catalog Number : ST661

Device Description : LDL Cholesterol Reagent (LDL) w/ Calibrator

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : MRR

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® MULTI-DRUG CONTROL UDT-CNTL - 00817302024630 Catalog Number : UDT-CNTL

Device Description : MULTI-DRUG CONTROL (UDT-CNTL)

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240 - 00817302024647 Catalog Number : AU-240

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

Device Class : 1

Duns Number: 962385787

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : Yes

Device Count : 1

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