Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R
• Generic Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
• Applicant: Qiagen Gaithersburg, Inc.; 19300 Germantown Rd.; Germantown, MD 20874
• PMA Number: P890064
• Supplement Number: S042
• Date Received: 09/29/2023
• Decision Date: 10/19/2023
• Product Code: MAQ
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
a supplier manufacturing site relocation for a test component