Md. Code Regs. 10.10.12.09

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.12.09 - Manufacturer's Requirements

A. Primary Standard. In addition to meeting the quality assessment plan requirements set forth in Regulation .05 of this chapter, a person seeking or holding a public health testing license shall ensure that public health testing program personnel meet the requirements and follow the manufacturer's test specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used.

B. A person seeking or holding a public health testing license shall ensure that public health testing program personnel pay attention to the precautions and warnings set forth in the manufacturer's testing specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used for:

(1) Product usage;

(2) Test system and kit controls; and

(3) The step-by-step instructions for performing the rapid HIV antibody test or rapid hepatitis C virus test.

Md. Code Regs. 10.10.12.09

Regulations .09 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); adopted permanently effective March 14, 2005 (32:5 Md. R. 580)
Regulation .09 amended effective April 1, 2013 (40:6 Md. R. 473)