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Title 42 Part 493 → Subpart A → §493.20

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart A → §493.20

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart A → §493.20

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

Title 42Chapter IVSubchapter GPart 493Subpart A → §493.20


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


§493.20   Laboratories performing tests of moderate complexity.

(a) A laboratory may qualify for a certificate to perform tests of moderate complexity provided that it restricts its test performance to waived tests or examinations and one or more tests or examinations meeting criteria for tests of moderate complexity including the subcategory of PPM procedures.

(b) A laboratory that performs tests or examinations of moderate complexity must meet the applicable requirements in subpart C or subpart D, and subparts F, H, J, K, M, and Q of this part. Under a registration certificate or certificate of compliance, laboratories also performing PPM procedures must meet the inspection requirements at §§493.1773 and 493.1777.

(c) If the laboratory also performs waived tests, compliance with subparts H, J, K, and M of this part is not applicable to the waived tests. However, the laboratory must comply with the requirements in §§493.15(e), 493.1773, and 493.1775.

[60 FR 20044, Apr. 24, 1995, as amended at 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]