Test, Urine Leukocyte

Device Code: 2416

Product Code(s): LJX

Device Classification Information

• Device Type ID: 2416
• Device Name: Test, Urine Leukocyte
• Regulation Description: Leukocyte Peroxidase Test.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.7675 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LJX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 13-93 IEEE Std 11073-10422-2016
  Health Informatics - Personal Health Device Communication, Part 10422: Device Specialization - Urine Analyzer

Total Product Life Cycle

• Device Type ID: 2416
• Device: Test, Urine Leukocyte
• Product Code: LJX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Leukocyte Peroxidase Test.
• CFR Regulation Number: 864.7675 [🔎]

Device Problems
False Negative Result	1
Pipette	1
Device Operates Differently Than Expected	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	May-18-2018

TPLC Last Update: 2019-04-02 20:11:33