| 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 |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 7-178 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Patricia Conville FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6942 patricia.conville@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.2410 | Culture Media, For Isolation Of Pathogenic Neisseria | Class 2 | JTY |
| §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 |
| §866.2350 | 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 |
| §866.2330 | Culture Media, Enriched | Class 1 | KZI |
| §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 |
| §866.2300 | Culture Media, Non-Selective And Non-Differential | Class 1 | JSG |
| There is no relevant guidance developed at this time. |