LD-L REAGENT

• K Number: K971398
• Device Name: LD-L REAGENT
• Manufacturer: CAROLINA LIQUID CHEMISTRIES CORP.
• Date Cleared: 1997-05-02 ( 17 days)
• Product Code: CFJ
• Regulation Number: 862.1440

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 862.1440 Lactate dehydrogenase test system.

(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

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