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§809.30. Restrictions on the sale, distribution and use of analyte specific reagents. — Inbound Citations

21 C.F.R. § 809.30

Statutory Authority

Cited by 5 regulations in release Current.

Citations to 21 C.F.R. § 809.30 as a whole

Citations to §809.30(c)

  • 21 C.F.R. § 809.30(g)
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    (g) The restrictions in paragraphs (c) through (f) of this section do not apply when reagents that otherwise meet the analyte specific reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

Citations to §809.30(d)

  • 21 C.F.R. § 809.30(g)
    Go to provision →
    (g) The restrictions in paragraphs (c) through (f) of this section do not apply when reagents that otherwise meet the analyte specific reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

Citations to §809.30(e)

  • 21 C.F.R. § 809.30(g)
    Go to provision →
    (g) The restrictions in paragraphs (c) through (f) of this section do not apply when reagents that otherwise meet the analyte specific reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

Citations to §809.30(f)

  • 21 C.F.R. § 809.30(g)
    Go to provision →
    (g) The restrictions in paragraphs (c) through (f) of this section do not apply when reagents that otherwise meet the analyte specific reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.