Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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7-260
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Standard | |
CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
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Scope/AbstractThis document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§866.3120 |
Dna Probe, Nucleic Acid Amplification, Chlamydia |
Class 1 |
MKZ |
§866.3120 |
Dna-Reagents, Chlamydia |
Class 1 |
LSK |
§866.3370 |
Dna-Reagents, Mycobacterium Spp. |
Class 1 |
LQF |
§866.3390 |
Dna-Reagents, Neisseria |
Class 2 |
LSL |
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Relevant FDA Guidance and/or Supportive Publications*
Draft Guidance for Industry and FDA Staff Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens, Issued December 2005.
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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. |