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Title 42 Part 493 → Subpart A → §493.5

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart A → §493.5

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart A → §493.5

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart A → §493.5


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart A—General Provisions


§493.5   Categories of tests by complexity.

(a) Laboratory tests are categorized as one of the following:

(1) Waived tests.

(2) Tests of moderate complexity, including the subcategory of PPM procedures.

(3) Tests of high 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:

(1) Certificate of registration or registration certificate.

(2) Certificate of waiver.

(3) Certificate for PPM procedures.

(4) Certificate of compliance.

(5) Certificate of accreditation.

[60 FR 20043, Apr. 24, 1995]