"specimen receptacle" means a device, whether vac...

"specimen receptacle" means a device, whether vacuum type or not, specifically intended by its manufacturer for the primary containment of specimens derived from human or animal body; (zt) "sponsor" includes a person, an investigator, a company or an institution or an organisation responsible for the initiation and management of a clinical investigation or clinical performance evaluation in India; (zu) "State Licensing Authority" means the authority designated by the State Government under sub-rule (2) of rule 8; (zv) "transient use" means a device intended for continuous use for less than sixty minutes; (zw) "transmissible agent", for the purpose of classification of in vitro diagnostic medical device, means an agent capable of being transmitted to a person, which causes communicable, infectious or contagious disease; (zx) words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them m the Act and the Drugs and Cosmetics Rules, 1945.