Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-150: CLSI H43-A2, Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition. (InVitro Diagnostics)
Date of Standard: 2006. |
| 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 Immunofluorescence-Based Flow Cytometry Methodology for The Immunophenotypic Analysis Of Leukemic And Lymphoma Cells |
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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 |
|
| FDA Technical Contact: |
| Kevin Maher, Ph.D. |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 4246 |
| Silver Spring MD 20993 |
| 301/796-6879 |
| Email: kevin.maher@fda.hhs.gov |
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