| CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
| Recognition Date | 2012-08-20 |
| Recognition List | 029 |
| Recognition Number | 7-197 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Yvonne Shea FDA/OMPT/CDRH/OIR/DMD/BAC2/ 301-796-0576 yvonne.shea@fda.hhs.gov |
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This standard includes the minimum identification criteria that can be used to rapidly identify a limited number of organisms commonly isolated from patient specimens. Although these tests do not rule out an occasional misidentification, those errors may not have important consequences with regard to patient outcome. Those situations in which rapid test results may have limitations are described. Unless those exceptions provide clinically useful information, confirmatory identification need not be done.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.2660 | Discs, Strips And Reagents, Microorganism Differentiation | Class 1 | JTO |
| §866.2660 | Gram Negative Identification Panel | Class 1 | LQM |
| §866.2660 | Instrument For Auto Reader Of Overnight Microorganism Identification System | Class 1 | LRH |
| §866.2660 | Kit, Anaerobic Identification | Class 1 | JSP |
| §866.2660 | Kit, Screening, Yeast | Class 1 | JXC |
| §866.3310 | Hepatitis A Test (Antibody And Igm Antibody) | Class 2 | LOL |
| Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 2009. |