HSV ELISA Negative Control EL0904
HSV ELISA Negative Control EL0904 is a Class II device made by DiaSorin Molecular LLC, cleared under FDA 510(k) K993754 on 9 Feb 2000 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 10816101022080), 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 | Number10816101022080 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993754 | Date9 Feb 2000 | StatusActive |
Official records
- AccessGUDID record 10816101022080
- FDA 510(k) database K993754
Across registries
- FDA 510(k) K993754 decided 9 Feb 2000 Active
- FDA GUDID UDI-DI 10816101022080 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K993754
- Listed FDA GUDID 10816101022080
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HSV ELISA Negative Control
- Generic name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control
- Model / Ref / Catalog
- EL0904
- Primary DI / UDI-DI
- 10816101022080
- 510(k) Number
- FDA product code
- MXJ
- GMDN term
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control
- Device class
- Class II
- Regulation number
- 866.3305
- GUDID distribution status
- In Commercial Distribution
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- HSV-1 ELISA IGG, MODEL EL0910G by Mrl Diagnostics
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