【ABC-KY】Announcement by Subsidiary Applied BioCode, Inc. that its 20-item Respiratory Pathogen Panel (RPP) and Automated Diagnostic System (MDx3000), combined with Thermo Fisher Scientific's KingFisher extraction instrument pre-processing system, have obtained US FDA market clearance.
ABC-KY's subsidiary, Applied BioCode, Inc., announced that its 20-item Respiratory Pathogen Panel (RPP) and Automated Diagnostic System (MDx3000), in combination with Thermo Fisher Scientific's KingFisher extraction instrument pre-processing system, have received US FDA 510(k) market clearance. This grants sales qualification in the US and is expected to positively impact the company's finances and operations.
📋 Article Processing Timeline
- 📰 Published: May 2, 2026 at 09:00
- 🔍 Collected: May 3, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: May 3, 2026 at 08:01 (1 min after Collected)
1. Product content:
The 20-item Respiratory Pathogen Panel (RPP) and Automated Diagnostic System (MDx 3000) developed by subsidiary Applied BioCode, Inc., in combination with Thermo Fisher Scientific's KingFisher extraction instrument pre-processing system, received US FDA 510(k) Clearance market approval on May 1, 2026, US local time. The RPP and MDx 3000 had previously obtained US FDA market approval in combination with bioMérieux and Roche Diagnostics' pre-processing systems, respectively. Now, obtaining US FDA approval to combine with Thermo Fisher Scientific's pre-processing system provides customers with an additional pre-processing system option and helps laboratory customers who already possess the KingFisher extraction instrument pre-processing system evaluate the introduction of the Group's RPP reagents and MDx 3000 automated diagnostic system.
2. Product mass production date: 2026/05/02
3. Impact on the company's finances and operations: The RPP reagents and MDx 3000 automated diagnostic system, combined with the KingFisher extraction instrument pre-processing system, have passed US FDA 510(k) medical device market clearance, which means obtaining sales qualification within the United States, and will have a positive impact on the Group's finances and operations.
4. Other matters that need to be specified (if the subject of the event or resolution is a public company or above, this material information also complies with the matters specified in Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act that have a significant impact on shareholders' equity or securities prices): None.
The 20-item Respiratory Pathogen Panel (RPP) and Automated Diagnostic System (MDx 3000) developed by subsidiary Applied BioCode, Inc., in combination with Thermo Fisher Scientific's KingFisher extraction instrument pre-processing system, received US FDA 510(k) Clearance market approval on May 1, 2026, US local time. The RPP and MDx 3000 had previously obtained US FDA market approval in combination with bioMérieux and Roche Diagnostics' pre-processing systems, respectively. Now, obtaining US FDA approval to combine with Thermo Fisher Scientific's pre-processing system provides customers with an additional pre-processing system option and helps laboratory customers who already possess the KingFisher extraction instrument pre-processing system evaluate the introduction of the Group's RPP reagents and MDx 3000 automated diagnostic system.
2. Product mass production date: 2026/05/02
3. Impact on the company's finances and operations: The RPP reagents and MDx 3000 automated diagnostic system, combined with the KingFisher extraction instrument pre-processing system, have passed US FDA 510(k) medical device market clearance, which means obtaining sales qualification within the United States, and will have a positive impact on the Group's finances and operations.
4. Other matters that need to be specified (if the subject of the event or resolution is a public company or above, this material information also complies with the matters specified in Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act that have a significant impact on shareholders' equity or securities prices): None.