Borrelia Negative Control BBN-6110
Borrelia Negative Control BBN-6110 is a Class II device made by Bion Enterprises, Ltd., cleared under FDA 510(k) K901054 on 5 Apr 1990 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI B110BBN61100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB110BBN61100 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK901054 | Date5 Apr 1990 | StatusActive |
Official records
- FDA 510(k) database K901054
Across registries
- FDA 510(k) K901054 decided 5 Apr 1990 Active
- FDA GUDID UDI-DI B110BBN61100 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K901054
- Listed FDA GUDID B110BBN61100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Borrelia Negative Control
- Generic name
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
- Model / Ref / Catalog
- BBN-6110
- Primary DI / UDI-DI
- B110BBN61100
- 510(k) Number
- FDA product code
- LSR
- GMDN term
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
- Device class
- Class II
- Regulation number
- 866.3830
- GUDID distribution status
- In Commercial Distribution
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