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Section 809.3
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Confidentiality of submitted information |
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Section 809.4
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Labeling for in vitro diagnostic products |
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Section 809.10
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Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic |
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Section 809.11
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General requirements for manufacturers and producers of in vitro diagnostic products |
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Section 809.20
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Restrictions on the sale, distribution and use of analyte specific reagents |
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Section 809.30
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Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing |
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Section 809.40
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Scope |