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Clinical Chemistry and Toxicology Devices

CFR - Hexokinase, Glucose

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862.1345 Glucose test system

CGA - DeviceGlucose Oxidase, Glucose

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NBW - System, Test, Blood Glucose, Over The Counter

LFR - Glucose Dehydrogenase, Glucose

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KHO - Fluorometer, For Clinical Use

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862.2560 Fluorometer for clinical use

KXT - Enzyme Immunoassay, Digoxin

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862.3320 Digoxin test system

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LAN - Enzyme Immunoassay, N-Acetylprocainamide

862.3170 Benzodiazepine test system

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JXM - Enzyme Immunoassay, Benzodiazepine

862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system

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NHG - Enzyme Immunoassay, Cortisol, Salivary

862.1690 Thyroid stimulating hormone test system

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JLW - Radioimmunoassay, Thyroid-Stimulating Hormone

DJG - Enzyme Immunoassay, Opiates

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862.3650 Opiate test system

LAF - Gas Chromatography, Methamphetamine

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862.3610 Methamphetamine test system

DJR - Enzyme Immunoassay, Methadone

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862.3620 Methadone test system

DKZ - Enzyme Immunoassay, Amphetamine

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862.3100 Amphetamine test system

862.3150 Barbiturate test system

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DIS - Enzyme Immunoassay, Barbiturate

862.3870 Cannabinoid test system

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LDJ - Enzyme Immunoassay, Cannabinoids

862.1810 Vitamin B[bdi1][bdi2] test system

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CDD - Radioassay, Vitamin B12

JJY - Multi-Analyte Controls, All Kinds (Assayed)

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862.1660 Quality control material (assayed and unassayed)

JHY - Colorimetric Method, Cpk Or Isoenzymes

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862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system

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MMI - Immunoassay Method, Troponin Subunit

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CGS - Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

MRG - System, Test, Vitamin D

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 862.1825 Vitamin D test system

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LCM - Enzyme Immunoassay, Phencyclidine

List of Device Rating & Review 
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Regulation Number & Device Type
(Click item to see USFDA device definition)
Product Code & Device Subtype
(See USFDA device information)
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