Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 07-145: CLSI H42-A2, Enumeration of Immunologically Defined Cell Populations by Flow Cytometry. (InVitro Diagnostics)
Date of Standard: 2007. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| Devices Affected: |
| DEVICES THAT UTILIZE FLOW CYTOMETRY METHODOLOGY AND DEVICES INTENDED FOR LYMPHOCYTE IMMUNOPHENOTYPING BY FLOW CYTOMETRY. |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5220 |
Counter, Differential Cell |
Class 2 |
GKZ |
| |
|
| Relevant Guidance: |
| 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 |
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| FDA Technical Contact: |
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