Glutathione, Red-cell

Device Code: 2281

Product Code(s): GII

Device Classification Information

• Device Type ID: 2281
• Device Name: Glutathione, Red-cell
• Regulation Description: Glutathione Reductase Assay.
• 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: 864.7375 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GII
• 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: 2281
• Device: Glutathione, Red-cell
• Product Code: GII
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Glutathione Reductase Assay.
• CFR Regulation Number: 864.7375 [🔎]

TPLC Last Update: 2019-04-02 20:08:51