Product Classification

• Device: test, euglobulin lysis
• Regulation Description: Euglobulin lysis time tests.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: JBO
• Submission Type: Enforcement Discretion
• Regulation Number: 864.7275
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.