Tray, Blood Collection

Device Code: 378

Product Code(s): GJE

Device Classification Information

• Device Type ID: 378
• Device Name: Tray, Blood Collection
• Regulation Description: Blood Specimen Collection Device.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1675 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GJE
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-142 CLSI GP43-A4 (Formerly H11-A4)
  Procedures For The Collection Of Arterial Blood Specimens; Approved Standard -- Fourth Edition
• 7-213 CLSI GP44-A4 (Formerly H18-A4)
  Procedures For The Handling And Processing Of Blood Specimens For Common Laboratory Tests; Approved Guideline-Fourth Edition

Total Product Life Cycle

• Device Type ID: 378
• Device: Tray, Blood Collection
• Product Code: GJE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Blood Specimen Collection Device.
• CFR Regulation Number: 862.1675 [🔎]

TPLC Last Update: 2019-04-02 19:33:43