| CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 7-260 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Li Li FDA/OMPT/CDRH/OIR/DMD/VIR1/ 301-796-6200 li.li2@fda.hhs.gov |
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This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.3390 | Dna-Reagents, Neisseria | Class 2 | LSL |
| §866.3370 | Dna-Reagents, Mycobacterium Spp. | Class 1 | LQF |
| §866.3120 | Dna Probe, Nucleic Acid Amplification, Chlamydia | Class 1 | MKZ |
| §866.3120 | Dna-Reagents, Chlamydia | Class 1 | LSK |
| Draft Guidance for Industry and FDA Staff Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens, Issued December 2005. |