Section 52-3.1 - Compliance with FDA regulations and manufacturers' instructions

Section 52-3.1 Compliance with FDA regulations and manufacturers' instructions.

(a) All antisera, reagents, devices, methods and procedures for tissue processing or transplantation-related testing shall be approved by the FDA, if such approval is available for the particular class or type of antiserum, reagent, device, method or procedure.

(b) All reagents shall be stored in labeled containers under conditions appropriate for each reagent as directed by the manufacturer and shall be removed from use after the expiration date. The reactivity, specificity and potency of each reagent shall be determined whenever a new lot is employed. All methods shall conform to manufacturers' instructions unless otherwise approved by the department upon submission of evidence that another method is equal or superior to the method described in the manufacturer's instructions.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete