Early Growth Response 1 (egr) Fish Probe Kit

Device Code: 2465

Product Code(s): OWK

Definition: The Egr1 Fish Probe Kit Is Intended To Detect Deletion Of The Lsi Egr1 Probe Target In Bone Marrow Specimens And May Be Used, In Addition To Cytogenetics, Other Biomarkers, Morphology, And Other Clinical Information, At The Time Of Diagnosis As An Ai

Device Classification Information

• Device Type ID: 2465
• Device Name: Early Growth Response 1 (egr) Fish Probe Kit
• Physical State: Device Is A Kit Containing Labeled FISH Probes
• Technical Method: Detection Of Early Growth Response Gene (EGR1) By Fluorescence In-situ Hybridization.
• Target Area: Not Applicable
• Regulation Description: Gene Expression Profiling Test System For Breast Cancer Prognosis.
• Regulation Medical Specialty: Immunology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.6040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OWK
• 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: 2465
• Device: Early Growth Response 1 (egr) Fish Probe Kit
• Product Code: OWK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Gene Expression Profiling Test System For Breast Cancer Prognosis.
• CFR Regulation Number: 866.6040 [🔎]

TPLC Last Update: 2019-04-02 20:12:52