493.5—Categories of tests by complexity.
(b)
A laboratory may perform only waived tests, only tests of moderate complexity, only PPM procedures, only tests of high complexity or any combination of these tests.
(c)
Each laboratory must be either CLIA-exempt or possess one of the following CLIA certificates, as defined in § 493.2 :
[60 FR 20043, Apr. 24, 1995]