Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-190: CLSI M50-A, Quality Control for Commerical Microbial Identification Systems. (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) |
|
|
| Devices Affected: |
| Microbial Identification system |
|
| Processes Affected: |
| Pre-IDE, 510(k), 510(k) exempt |
|
| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2660 |
Gram Positive Identification Panel |
Class 1 |
LQL |
| §866.2660 |
Instrument For Auto Reader Of Overnight Microorganism Identification System |
Class 1 |
LRH |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
|
