Sulfolyser BJ350971
Sulfolyser BJ350971 is a Class I device made by Sysmex Corporation, listed in FDA GUDID since 30 Nov 2022 (UDI-DI 04987562422975), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04987562422975 | Date30 Nov 2022 | StatusListed |
Official records
- AccessGUDID record 04987562422975
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Sulfolyser
- Generic name
- Total haemoglobin (totHb) IVD, reagent
- Model / reference
- BJ350971
- Primary DI / UDI-DI
- 04987562422975
- FDA product code
- GGK
- GMDN term
- Total haemoglobin (totHb) IVD, reagent
- Device class
- Class I
- Regulation number
- 864.8540
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 1.5 Liter
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