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

ALKALINE PICRATE, COLORIMETRY, CREATININE (CGX) (1) C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL (DCK) (1) CRESOLPHTHALEIN COMPLEXONE, CALCIUM (CIC) (1) ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL (CHH) (1) HEXOKINASE, GLUCOSE (CFR) (1) KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE (JQB) (1) LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL (LBS) (1) Ldl & Vldl Precipitation, Hdl (LBR) (1) NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE (CFJ) (1) Photometric method, iron (non-heme) (JIY) (1)

Premarket Exempt

Clear

ClearChem Diagnostics Inc. Calcium - 00852169008119 Catalog Number : CAL1080

Device Description : In Vitro Diagnostics testing kit R1:4X60mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CIC

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Creatinine (Jaffe) - 00852169008126 Catalog Number : CRE1120

Device Description : In Vitro Diagnostics testing kit R1:3X50mL, R2:3X10mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CGX

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT) - 00852169008133 Catalog Number : GGT1130

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

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : JQB

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Glucose - 00852169008140 Catalog Number : GLU1140

Device Description : In Vitro Diagnostics testing kit R1:4X60mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CFR

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Cholesterol, Total - 00852169008157 Catalog Number : CHL1100

Device Description : In Vitro Diagnostics testing kit R1:4X60mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol - 00852169008164 Catalog Number : HDL1210

Device Description : In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : LBS

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP) - 00852169008171 Catalog Number : CRP1320

Device Description : In Vitro Diagnostics testing kit R1:1X20mL, R2:1X20mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Iron - 00852169008188 Catalog Number : IRN1150

Device Description : In Vitro Diagnostics testing kit R1:3X60mL, R2:3X12mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : JIY

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Lactate Dehydogenase (LDH) - 00852169008195 Catalog Number : LDH1170

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

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CFJ

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol - 00852169008201 Catalog Number : LDL1230

Device Description : In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : LBR

Prescription Use : No

Device Count : 1

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