Mouse AntiTTF1 Concentrate

Product Number 18-0221, no 510(k) number, Product Code MXZ, lot code 40280262.

Hematology and Pathology Devices

2

No

The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.

Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.