Mumps Negative Control MUN-8010
Mumps Negative Control MUN-8010 is a Class I device made by Bion Enterprises, Ltd., cleared under FDA 510(k) K894624 on 16 Oct 1989 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI B110MUN80100), 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 | NumberB110MUN80100 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK894624 | Date16 Oct 1989 | StatusActive |
Official records
- FDA 510(k) database K894624
Across registries
- FDA 510(k) K894624 decided 16 Oct 1989 Active
- FDA GUDID UDI-DI B110MUN80100 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K894624
- Listed FDA GUDID B110MUN80100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mumps Negative Control
- Generic name
- Mumps virus immunoglobulin M (IgM) antibody IVD, control
- Model / Ref / Catalog
- MUN-8010
- Primary DI / UDI-DI
- B110MUN80100
- 510(k) Number
- FDA product code
- GRA
- GMDN term
- Mumps virus immunoglobulin M (IgM) antibody IVD, control
- Device class
- Class I
- Regulation number
- 866.3380
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GRA (Antiserum, Fluorescent, Mumps Virus).