Test, Equipment, Automated Bloodborne Pathogen

Device Code: 3128

Product Code(s): MZA

Device Classification Information

• Device Type ID: 3128
• Device Name: Test, Equipment, Automated Bloodborne Pathogen
• Review Panel: Immunology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: Contact ODE
• FDA Device Classification: Class Not Classified Medical Device
• Product Code: MZA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3128
• Device: Test, Equipment, Automated Bloodborne Pathogen
• Product Code: MZA

Premarket Reviews
Manufacturer	Decision
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
ROCHE DIAGNOSTICS OPERATIONS INC.
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
False Positive Result	12
Incorrect Or Inadequate Test Results	3
Device Operates Differently Than Expected	2
Adverse Event Without Identified Device Or Use Problem	2
Smoking	2
Appropriate Term/Code Not Available	2
Use Of Device Problem	1
High Test Results	1
Charred	1
False Negative Result	1
Total Device Problems	27

TPLC Last Update: 2019-04-02 20:24:17