Labeling of Home-Use In Vitro Testing Products; Approved Guideline<\/p>\n","protected":false},"excerpt":{"rendered":"
Abstract Labeling of Home-Use In Vitro Testing Products; Approved Guideline (NCCLS document GP14-A) outlines the information that should be available to the home user of in vitro testing products. GP14-A is intended for use primarily by manufacturers. The document will enable the manufacturer to facilitate proper use of its products by providing sufficient information to the user in a usable format. In Section 2, GP14-A briefly describes the information that should appear on the outside of the product’s package. Section 3 describes the information that should appear on the package insert. In addition, Section 4 describes methods for premarket testing of the product’s labeling and documentation; Section 5 gives a brief overview of premarket performance testing of the product by clinical laboratorians and by the target market population. [NCCLS. Labeling of Home-Use In Vitro Testing Products; Approved Guideline. NCCLS document GP14-A (ISBN 1-56238-299-3). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1996.<\/p>\n","protected":false},"featured_media":1987,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_cat":[26],"product_tag":[],"yoast_head":"\n