Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.12 - Medical Laboratories - Public Health HTV Testing Programs
Section 10.10.12.09 - Manufacturer's Requirements

Universal Citation: MD Code Reg 10.10.12.09

Current through Register Vol. 51, No. 19, September 20, 2024

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.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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