IMMUNALYSIS CORPORATION 206-0192 Immunalysis Corporation

This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.

Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.

TIDI Positioning Aid Kits Kit, Various Sizes 8 per Set

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.

BIO-COMP CRKSCRW FT VENTD 5.5X14.7MM

SCREW, CANN. INT., FULL THREAD

SCRW,CANN. INT.,W/DISP SHTH

TIGHTROPE ABS, BUTTON, 8 X 12 MM

These Stryker 3002 Ex Secure 2 Beds are in fully functional condition and include electric controls for adjusting the head, foot, and height positions, along with Trendelenburg capabilities. The bed has adjustable side rails and a secure braking system. It also features pressure-relief surfaces.

Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).

This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.

Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.

TIDI Positioning Aid Kits Kit, Various Sizes 8 per Set

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.