Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-179: CLSI M27-S3, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement. (InVitro Diagnostics)
Date of Standard: 2008. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF MICROBIOLOGY (DMD) |
|
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| Devices Affected: |
| Antifungal Susceptibility minimum inhibitory concentration (MIC) and disk diffusion devices |
|
| Processes Affected: |
|
| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.1620 |
Discs, Elution |
Class 2 |
LTX |
| §866.1620 |
Susceptibility Test Discs, Antimicrobial |
Class 2 |
JTN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.1640 |
Susceptibility Test Plate, Antifungal |
Class 2 |
NGZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.1700 |
Culture Media, Antifungal, Susceptibility Test |
Class 2 |
MJE |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Yvonne Shea |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5510 |
| Silver Spring MD 20993 |
| 301/796-0576 |
| Email: yvonne.shea@fda.hhs.gov |
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