DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

• K Number: K011033
• Device Name: DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
• Manufacturer: DADE BEHRING, INC.
• Date Cleared: 2001-06-07 ( 63 days)
• Product Code: JIH
• Regulation Number: 862.3560
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 862.3560 Lithium test system.

(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.