Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-189: CLSI M47-A, Principles and Procedures for Blood Cultures. (InVitro Diagnostics)
Date of Standard: 2007. |
| 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: |
| Manual (broth, biphasic and lysis-centrifugation); automated (BACTEC, BatT/Alert and Versa/TREK) blood culture systems |
|
| Processes Affected: |
|
| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2300 |
Culture Media, Non-Selective And Non-Differential |
Class 1 |
JSG |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2560 |
Monitor, Microbial Growth |
Class 1 |
JTA |
| §866.2560 |
System, Blood Culturing |
Class 1 |
MDB |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Alexandra Wong |
| FDA/CDRH/OIVD |
| 10993 New Hampshire Avenue Building 66, Room 5502 |
| Silver Spring MD 20993 |
| 301/796-6210 |
| Email: alexandra.wong@fda.hhs.gov |
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