Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 13-9: CLSI / NCCLS AUTO2-A2, Laboratory Automation: Bar Codes for Specimen Container Identification. (Software/Informatics)
Date of Standard: 2006. |
| Addresses of Standards Organizations: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
| National Committee for Clinical Laboratory Standards (NCCLS) |
| 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 COMPLIANCE (OC) |
|
|
| Devices Affected: |
| Auto Analyses, Reagent Containers |
|
| Processes Affected: |
|
| Type of Standard: |
| International, Horizontal |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.2100 |
Calculator/Data Processing Module, For Clinical Use |
Class 1 |
JQP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.3250 |
Container, Specimen Mailer And Storage, Sterile |
Class 1 |
KDT |
| §864.3250 |
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
Class 1 |
KDW |
| §864.3250 |
Container, Specimen, Sterile |
Class 1 |
FMH |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| James Callaghan |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5658 |
| Silver Spring MD 20993 |
| 301/796-6137 |
| Email: james.callaghan@fda.hhs.gov |
|
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