DxSelect™ - Stop Reagent EL0105
DxSelect™ - Stop Reagent EL0105 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 11 Jul 2017 (UDI-DI 10816101022301), 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 | Number10816101022301 | Date11 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993754 | Date9 Feb 2000 | StatusActive |
Official records
- AccessGUDID record 10816101022301
- FDA 510(k) database K993754
Across registries
- FDA 510(k) K993754 decided 9 Feb 2000 Active
- FDA GUDID UDI-DI 10816101022301 listed 11 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K993754
- Listed FDA GUDID 10816101022301
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DxSelect™ - Stop Reagent
- Generic name
- Sulphuric acid stop solution reagent IVD
- Model / Ref / Catalog
- EL0105
- Primary DI / UDI-DI
- 10816101022301
- 510(k) Number
- FDA product code
- MXJ
- GMDN term
- Sulphuric acid stop solution reagent IVD
- Device class
- Class II
- Regulation number
- 866.3305
- GUDID distribution status
- In Commercial Distribution
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