Gold Standard Diagnostics Corporation 720-430 Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit

The Olympus LF-P small diameter tracheal intubation fiberscope features an ultrathin insertion tube, making it perfect for patients with small airways. Leveraging Olympus' extensive experience in medical optics, the LF-P provides exceptional optical performance and innovative 120° up/down angulation capabilities.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.