Elecsys EBV EBNA IgG
510(k) K260221
Elecsys EBV EBNA IgG is a Class I device made by Roche Diagnostics Corp., cleared under FDA 510(k) K260221 on 2 Oct 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260221 | Date2 Oct 2026 | StatusActive |
Official records
- FDA 510(k) database K260221
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LSE
- FDA applicant
- Roche Diagnostics
- Device class
- Class I
- Regulation
- 21 CFR Part 866.3235
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
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