Most products sold by AT First Diagnostic LLC have FDA clearance for the US marketplace already; Please refer to the specific product information for additional information on:
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Product Use Instructions
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Package Insert
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Statistical Information
Also, all products sold by First Diagnostic are manufactured under strict control through cGMP (Good Manufacturing Practices) as overseen by the FDA guidlines. These certifications attest to the quality standards set and achieved for the manufacture of the entire First Diagnostic product line.