Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-184: CLSI M40-A, Quality Control of Microbiological Transport Systems; Approved Standard. (InVitro Diagnostics)
Date of Standard: 2003. |
| 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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
|
| (2) | OFFICE OF DEVICE EVALUATION (ODE) |
|
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| Devices Affected: |
| All specimen collection kits and transport media used for preparation, storage and transporting of human specimens to a laboratory test site. |
|
| Processes Affected: |
|
| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2360 |
Culture Media, Selective Broth |
Class 1 |
JSD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2390 |
Culture Media, Anaerobic Transport |
Class 1 |
JSL |
| §866.2390 |
Culture Media, Non-Propagating Transport |
Class 1 |
JSM |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.2900 |
Device, Parasite Concentration |
Class 1 |
LKS |
| §866.2900 |
Device, Specimen Collection |
Class 1 |
LIO |
| §866.2900 |
System, Transport, Aerobic |
Class 1 |
JTW |
| §866.2900 |
Transport Systems, Anaerobic |
Class 1 |
JTX |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Raquel Peat |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5561 |
| Silver Spring MD 20993 |
| 301/796-6218 |
| Email: raquel.peat@fda.hhs.gov |
|
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