Enzyme Immunoassay, Gentamicin

Device Code: 6197

Product Code(s): LCD

Device Classification Information

• Device Type ID: 6197
• Device Name: Enzyme Immunoassay, Gentamicin
• Regulation Description: Gentamicin Test System.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.3450 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LCD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 6197
• Device: Enzyme Immunoassay, Gentamicin
• Product Code: LCD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Gentamicin Test System.
• CFR Regulation Number: 862.3450 [🔎]

Device Problems
High Test Results	3
Adverse Event Without Identified Device Or Use Problem	3
Total Device Problems	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics, Inc.	II	Jun-13-2018
2	bioMerieux, Inc.	II	Sep-15-2018

TPLC Last Update: 2019-04-02 21:18:40