I.S.E. Cl D200-0016
I.S.E. Cl D200-0016 is a Class II device made by Randox Laboratories, Ltd., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273210545), 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 | Number05055273210545 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05055273210545
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- I.S.E. Cl
- Generic name
- Chloride (Cl-) electrode IVD
- Model / Ref / Catalog
- D200-0016
- Primary DI / UDI-DI
- 05055273210545
- FDA product code
- CGZ
- GMDN term
- Chloride (Cl-) electrode IVD
- Device class
- Class II
- Regulation number
- 862.1170
- GUDID distribution status
- In Commercial Distribution
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