Sabs SP8399
Sabs SP8399 is a medical device (FDA Class I; FDA product code JJE, Analyzer, Chemistry (Photometric, Discrete), For Clinical Use) made by Randox Laboratories, Ltd., listed in FDA GUDID since 26 Sep 2016 (UDI-DI 05055273214444), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055273214444 | Date26 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05055273214444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Sabs
- Generic name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use
- Model / Ref / Catalog
- SP8399
- Primary DI / UDI-DI
- 05055273214444
- FDA product code
- JJE
- GMDN term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use
- Device class
- Class I
- Regulation number
- 862.2160
- GUDID distribution status
- In Commercial Distribution
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