CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Address:1800 N.W. 65TH AVE.,PLANTATION,FL,33313,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) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Enzymatic, Carbon-Dioxide (KHS) (1) Hexokinase, Glucose (CFR) (1) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Photometric Method, Iron (Non-Heme) (JIY) (1) Photometric Method, Magnesium (JGJ) (1)

Premarket Exempt

No Yes

Clear

Cholesterol Reagent - 00812137011930 Catalog Number : 501-406

Device Description : For the quantitative determination of Total Cholesterol in serum.

Device Class : 1

Duns Number: 048144997

Premarket Exempt : No

Product Code : CHH

Prescription Use : No

Device Count : 1

Carbon Dioxide Reagent - 00812137011947 Catalog Number : 501-407

Device Description : For the quantitative determination of Carbon Dioxide in serum. For in vitro dia For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.

Device Class : 2

Duns Number: 048144997

Premarket Exempt : No

Product Code : KHS

Prescription Use : No

Device Count : 1

CK-NAC Reagent Set - 00812137011954 Catalog Number : 501-408

Device Description : For the quantitative determination of creatine kinase activity in serum. Serum c For the quantitative determination of creatine kinase activity in serum. Serum creatinine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.¹ Determination of creatine kinase and lactate dehydrogenase isoenzymes provides a definitive diagnosis of acute myocardial infarction.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : CGS

Prescription Use : No

Device Count : 2

Creatinine Reagent Set - 00812137011961 Catalog Number : 501-409

Device Description : For the quantitative determination of creatinine in serum. For in vitro diagnos For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : CGX

Prescription Use : No

Device Count : 2

GGT Reagent Set - 00812137011978 Catalog Number : 501-410

Device Description : For the quantitative kinetic determination of gamma glutamyl transferase (GGT) a For the quantitative kinetic determination of gamma glutamyl transferase (GGT) activity in serum. GGT measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis, and primary and secondary tumors. Elevated GGT levels appear earlier and are more pronounced than those of other liver enzymes, in cases of obstructive jaundice and metastatic neoplasms.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JQB

Prescription Use : No

Device Count : 2

Glucose Reagent - 00812137011985 Catalog Number : 501-411

Device Description : For the in vitro quantitative measurement of glucose in serum. The measurement For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically significant in diabetes, hypoglycemia, and various adrenal and pituitary disorders.

Device Class : 2

Duns Number: 048144997

Premarket Exempt : No

Product Code : CFR

Prescription Use : No

Device Count : 1

Iron Reagent Set - 00812137011992 Catalog Number : 501-412

Device Description : For the quantitative determination of iron in serum. For in vitro diagnostic use only.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JIY

Prescription Use : No

Device Count : 2

LDH Reagent Set - 00812137012005 Catalog Number : 501-413

Device Description : For the in vitro quantitative kinetic determination of lactate dehydrogenase act For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : CFJ

Prescription Use : No

Device Count : 2

Magnesium Reagent Set - 00812137012012 Catalog Number : 501-414

Device Description : For the quantitative determination of magnesium in serum. For in vitro diagnosti For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JGJ

Prescription Use : No

Device Count : 4

Phosphorus Reagent - 00812137012029 Catalog Number : 501-415

Device Description : For the quantitative determination of Inorganic Phosphorus in serum.

Device Class : 1

Duns Number: 048144997

Premarket Exempt : No

Product Code : CEO

Prescription Use : No

Device Count : 1

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