Sulfolyser Sls-210A
Sulfolyser Sls-210A is a Class I device made by Sysmex Corporation, listed in FDA GUDID since 4 Nov 2022 (UDI-DI 10664369200159), 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 | Number10664369200159 | Date4 Nov 2022 | StatusListed |
Official records
- AccessGUDID record 10664369200159
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- Withdrawn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
- SLS-210A
- Primary DI / UDI-DI
- 10664369200159
- 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 — 500 Milliliter
Similar devices
Other devices filed under FDA product code GGK (Products, Red-Cell Lysing Products).
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- LYSING & HEMOGLOBIN S-REAGENT J & S by Jasins & Sayles Associates, Inc.
- ACETIC ACID, 3% V/V by E K Ind., Inc.
- LYSE-TEC by Medilab Corp.
- ELUAID by Ortho Diagnostic Systems, Inc.
- ACETIC ACID 1% V/V by E K Ind., Inc.
- THROMBO PLUS by W. Sarstedt, Inc.