FIDIS DSDNA
by Biomedical Diagnostics (Bmd) SA
510(k) K060380
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060380 | Date2 May 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LSW
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5100
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
FIDIS DSDNA is an anti-DNA antibody, antigen and control device used in immunology testing. It is classified as a Class II medical device under FDA regulation number 866.5100 with product code LSW.
The device received FDA 510(k) clearance (K060380) on May 2, 2006, following a traditional review process. It was submitted by Biomedical Diagnostics (Bmd) SA and is classified under the Immunology specialty.
Other devices from Biomedical Diagnostics (Bmd) SA
Questions
AI-generated answers, 6 Oct 2026
What is the FIDIS DSDNA device used for?
The FIDIS DSDNA device is used as an anti-DNA antibody, antigen and control in immunology testing, as stated in its description for laboratory applications involving antibody detection.
How is the FIDIS DSDNA supplied and is it sterile or single-use?
The device data does not specify supply format, sterility, or single-use/reuse status; these details are not included in the provided information about its classification, clearance, or intended use as an antigen and control in immunology testing.
What regulatory pathway was used for the FIDIS DSDNA clearance?
The FIDIS DSDNA received FDA 510(k) clearance through a traditional review process, as indicated by the clearance_type field and the K060380 number, following submission by Biomedical Diagnostics (Bmd) SA on February 14, 2006.