Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-180: CLSI M34-A, Western Blot Assay for Antibodies to Borrelia burgdorferi. (InVitro Diagnostics)
Date of Standard: 2000. |
| 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) |
|
|
| Devices Affected: |
| Borrelia burgdorferi antibody test reagents regulated under 21 CFR 866.3830 with product code LSR; Reagent, Borrelia Serological Reagent |
|
| Processes Affected: |
|
| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.3830 |
Reagent, Borrelia Serological Reagent |
Class 2 |
LSR |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Prasad Rao |
| FDA/CDRH/OIVD |
| 2098 Gaither Road, HFZ-440 |
| Rockville MD 20850 |
| 240/276-0722 |
| Email: prasad.rao@fda.hhs.gov |
|
|
