| CLSI H56-A (Replaces H56-P) Body Fluid Analysis for Cellular Composition; Approved Guideline. |
| Recognition Date | 2008-09-09 |
| Recognition List | 020 |
| Recognition Number | 7-163 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Takeesha Taylor-Bell FDA/OMPT/CDRH/OIR/DIHD/HEMB/ 240-402-6566 Takeesha.Taylor-Bell@fda.hhs.gov |
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This guideline provides users with recommendations for collection and transport of body fluids, numeration and identification of cellular components, and guidance for qualitative and quantitative assessment of body fluid.
| Regulation Number | Device Name | Device Class | Product Code |
| §864.5220 | Counter, Differential Cell | Class 2 | GKZ |
| §864.5200 | Counter, Cell, Automated (Particle Counter) | Class 2 | GKL |
| Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA, Issued December 2001. |