Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2a:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2A (pt 3/3)
Character Range: 342121–343087

of a number of tests, observations or measurements.
specimen receptacle means a device, whether vacuum‑type or not, specifically intended by its manufacturer for the primary containment and preservation of a specimen derived from the human body for the purpose of in vitro diagnostic examination.
Note 1: A specimen receptacle is considered to be an IVD medical device.
Note 2: A product for general laboratory use is not an IVD medical device unless the product is specifically intended by its manufacturer to be used for in vitro diagnostic examination.

1.7  Other IVD medical devices are Class 2 IVD medical devices
  An IVD medical device not mentioned in this Schedule is classified as a Class 2 IVD medical device or a Class 2 in‑house IVD medical device.

1.8  IVD medical devices intended for export only
  Despite clauses 1.1 to 1.7, an IVD medical device is classified as a Class 1 IVD medical device if it is intended by the manufacturer for export only.