---
kind: "section"
citation: "42 C.F.R. § 493.5"
title: "42"
number: "493.5"
heading: "Categories of tests by complexity."
url: "https://uscodex.org/cfr/42/493.5"
---

# §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](/cfr/42/493.2.md):
  - (1) **Certificate of registration or registration certificate.**
  - (2) **Certificate of waiver.**
  - (3) **Certificate for PPM procedures.**
  - (4) **Certificate of compliance.**
  - (5) **Certificate of accreditation.**

## Notes

### Amendments

[60 FR 20043, Apr. 24, 1995]

### Source

Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

### Amendments

[60 FR 20043, Apr. 24, 1995]