Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Device: ID CORE XT
• Classification Name: molecular erythrocyte typing test
• Generic Name: molecular erythrocyte typing test
• Applicant: Progenika Biopharma, S.A.; ibaizabal bidea, edificio 504 parque technologico de bizkaia; Derio, Bizkaia ; spain 48160
• PMA Number: BP170154
• Supplement Number: S006
• Date Received: 08/14/2020
• Decision Date: 09/08/2020

• Decision: 30-Day Notice - No 135-Day Supplement Needed
• Product Code: PEP [ Registered Establishments with PEP ]
• Advisory Committee: Hematology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No