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

ALBUMIN, FITC, ANTIGEN, ANTISERUM, CONTROL (DDZ) (1) ASSAY, GLYCOSYLATED HEMOGLOBIN (LCP) (1) Acid, uric, uricase (colorimetric) (KNK) (1) BIURET (COLORIMETRIC), TOTAL PROTEIN (CEK) (1) Calibrator, multi-analyte mixture (JIX) (1) Calibrator, secondary (JIT) (1) Ferrozine (colorimetric) iron binding capacity (JMO) (1) LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES (CDT) (1) LOWRY (COLORIMETRIC), TOTAL PROTEIN (JGP) (1) PHOTOMETRIC METHOD, MAGNESIUM (JGJ) (1) Phosphomolybdate (colorimetric), inorganic phosphorus (CEO) (1)

Premarket Exempt

Clear

ClearChem Diagnostics Inc. Magnesium - 00852169008218 Catalog Number : MAG1180

Device Description : In Vitro Diagnostics testing kit R1:4X30mL, R2:4X30mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : JGJ

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Inorganic Phosphorous - 00852169008225 Catalog Number : PHO1300

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

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : CEO

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. TIBC-Direct - 00852169008232 Catalog Number : ITI1160

Device Description : In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : JMO

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Protein, Total - 00852169008249 Catalog Number : TPR1310

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

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : CEK

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Triglycerides - 00852169008256 Catalog Number : TRG1400

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

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : CDT

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Uric Acid - 00852169008263 Catalog Number : URA1500

Device Description : In Vitro Diagnostics testing kit R1:5X30mL

Device Class : 1

Duns Number: 010655581

Premarket Exempt : No

Product Code : KNK

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. MicroAlbumin - 00852169008270 Catalog Number : MAL1010

Device Description : In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : JIT, DDZ

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. Hemoglobin A-1c - 00852169008287 Catalog Number : HGB1200

Device Description : In Vitro Diagnostics testing kit Buffer:1X36mL, R1a:1X16mL, R2b:1X6.7mL, R2:1X10.1mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : LCP

Prescription Use : No

Device Count : 1

ClearChem Diagnostics Inc. MicroProtein, Total - 00852169008294 Catalog Number : MPN2020

Device Description : In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL

Device Class : 2

Duns Number: 010655581

Premarket Exempt : No

Product Code : JGP, JIX

Prescription Use : No

Device Count : 1

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