Single laboratory,

Single laboratory, for purposes of an ADLT, means:
(1) The laboratory, as defined in 42 CFR 493.2, which furnishes the test, and that may also design, offer, or sell the test; and
(2) The following entities, which may design, offer, or sell the test:
(i) The entity that owns the laboratory.
(ii) The entity that is owned by the laboratory.


42 CFR § 414.502

Scoping language

For purposes of this subpart -

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