Resources

How to Apply for a CLIA Certificate

CLIA LAW
(Clinical Laboratory Improvement
Amendments (42 USC 263a)

Laboratory Quick Start Guide

CLIA Regulations
Standards and Certification: Laboratory
Requirements (42 CFR 493)

Source: GPO (Government Printing Office)
Federal Digital System

CLIA Guidelines
CMS Survey Procedures and Interpretive
Guidelines for Laboratories and Laboratory
Services (Appendix C)

USEFUL ARTICLES

*Information provided by the CDC.
Selecting a link will take you to the CDC’s website in a new browser tab.

INDICAID OTC DOWNLOADS

NDC NUMBERS:
60008-0407-80 (2-Pack)

FDA Letter of Authorization	INDICAID Omicron Variant Update
Expiration Extension – 90 Day Extension	INDICAID OTC Healthcare Professional Fact Sheet
INDICAID OTC Instructions For Use (English)	INDICAID OTC Healthcare Instructions For Use
INDICAID OTC Instructions For Use (Espanol)	*INDICAID OTC FAQ’s For Consumers
INDICAID OTC Safety Data Sheet	PHASE DIAGNOSTICS Conditions of Sale
INDICAID OTC Catalogue (Sales Sheet)	INDICAID OTC Catalogue (Sales Sheet) – Espanol

INDICAID PoC DOWNLOADS

FDA Letter of Authorization	INDICAID Quick Reference Guide
FDA Letter of Authorization – 90 Day Extension FDA Letter of Authorization – Shelf Life	INDICAID PoC Instructions for Use
INDICAID Catalogue (Sales Sheet)	INDICAID Patient Fact Sheet
INDICAID Catalogue (Sales Sheet) – Espanol	INDICAID Healthcare Provider Fact Sheet
INDICAID Safety Data Sheet	INDICAID FAQ’s For Patients
INDICAID Omicron Variant Update	INDICAID FAQ’s For Healthcare Providers
PHASE DIAGNOSTICS Conditions of Sale	INDICAID Rapid Antigen Test Quality Controls for (IFU)