Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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7-178
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Standard | |
CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
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Scope/AbstractThis standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§866.2350 |
Culture Media, Antibiotic Assay |
Class 1 |
JSA |
§866.2350 |
Culture Media, General Nutrient Broth |
Class 1 |
JSC |
§866.2350 |
Culture Media, Vitamin Assay |
Class 1 |
JSB |
§866.2350 |
Media, Culture, Amino Acid Assay |
Class 1 |
JRZ |
§866.2320 |
Culture Media, Multiple Biochemical Test |
Class 1 |
JSE |
§866.2320 |
Culture Media, Non-Selective And Differential |
Class 1 |
JSH |
§866.2320 |
Culture Media, Single Biochemical Test |
Class 1 |
JSF |
§866.2360 |
Culture Media, Selective And Differential |
Class 1 |
JSI |
§866.2360 |
Culture Media, Selective And Non-Differential |
Class 1 |
JSJ |
§866.2360 |
Culture Media, Selective Broth |
Class 1 |
JSD |
§866.2300 |
Culture Media, Non-Selective And Non-Differential |
Class 1 |
JSG |
§866.2330 |
Culture Media, Enriched |
Class 1 |
KZI |
§866.2410 |
Culture Media, For Isolation Of Pathogenic Neisseria |
Class 2 |
JTY |
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |