Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-154: CLSI MM02-A2, Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays. (InVitro Diagnostics)
Date of Standard: 2002. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) |
|
| (2) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
|
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| Devices Affected: |
| B-cell and T-cell Receptor Gene Rearrangement Assays |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5220 |
Dna-Probe, B And T Lymphocyte |
Class 2 |
MAM |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Karen Bijwaard, MS |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5614 |
| Silver Spring MD 20993 |
| 301/796-6162 |
| Email: karen.bijwaard@fda.hhs.gov |
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