Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

Device Code: 283

Product Code(s): CFH

Device Classification Information

• Device Type ID: 283
• Device Name: Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
• Regulation Description: Lactate Dehydrogenase Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1440 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CFH
• 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: 283
• Device: Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
• Product Code: CFH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Lactate Dehydrogenase Test System.
• CFR Regulation Number: 862.1440 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
High Test Results	3
Low Test Results	3
Mechanical Problem	2
Pump	1
Appropriate Term/Code Not Available	1
Holder	1
Total Device Problems	15

TPLC Last Update: 2019-04-02 19:32:08