CLEARCHEM DIAGNOSTICS INC.

Address:1710 E GREVILLEA CT,ONTARIO,CA,91761,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

DIAZO COLORIMETRY, BILIRUBIN (CIG) (2) ENZYMATIC, CARBON-DIOXIDE (KHS) (1) NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES (CGS) (1) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (1) NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES (CJE) (1) Nadh oxidation/nad reduction, ast/sgot (CIT) (1) SACCHAROGENIC, AMYLASE (CIJ) (1) BROMCRESOL GREEN DYE-BINDING, ALBUMIN (CIX) (1) UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN (CDQ) (1)

Premarket Exempt

Clear

ClearChem Diagnostics Inc. Albumin - 00852169008010 Catalog Number : ALB1000

Device Description : In Vitro Diagnostics testing R1: 4X60mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CIX

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) - 00852169008027 Catalog Number : ALP1010

Device Description : In Vitro Diagnostics testing kit R1:3X48mL, R2:3X12mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CJE

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Alanine aminotransferase (ALT) - 00852169008034 Catalog Number : ALT1020

Device Description : In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : CKA

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Amylase - 00852169008041 Catalog Number : AMY1030

Device Description : In Vitro Diagnostics testing kit R1:3X60mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CIJ

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Aspartate aminotransferase (AST) - 00852169008058 Catalog Number : AST1040

Device Description : In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CIT

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN) - 00852169008065 Catalog Number : BUN1070

Device Description : In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CDQ

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Carbon Dioxide (CO2) - 00852169008072 Catalog Number : CAR1090

Device Description : In Vitro Diagnostics testing kit R1:6X30mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : KHS

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Creatine Kinase (CK) - 00852169008089 Catalog Number : CPK1110

Device Description : In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CGS

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Bilirubin, Direct - 00852169008096 Catalog Number : BRD1050

Device Description : In Vitro Diagnostics testing kit R1:3X28mL, R2:3X7mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CIG

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Bilirubin, Total - 00852169008102 Catalog Number : BRB1060

Device Description : In Vitro Diagnostics testing kit R1:3X42mL, R2:3X11mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CIG

Prescription Use : No

Device Count : 1

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