Identity
- Trade Name
- SULFOLYSER FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, reagent FDA UDI
- Device Name
- Reagent for the automated determination of hemoglobin concentration of blood FDA UDI
- Model / Reference
- SLS-210A FDA UDI
- Description
- Reagent for the automated determination of hemoglobin concentration of blood FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10664369200159 FDA UDI
- FDA Product Code
- GGK FDA UDI
- GMDN Term
- Total haemoglobin (totHb) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 500 Milliliter FDA UDI
Category: Total haemoglobin (totHb) IVD, reagent
Sulfolyser by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total haemoglobin (totHb) IVD, reagent.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- hemochroma PLUS Microcuvettes — IMMUNOSTICS, INC. · Class II
- Teco Diagnostics Hemoglobin Reagent Set — TECO DIAGNOSTICS · Class II
- hemochroma PLUS Starter Kit — IMMUNOSTICS, INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Teco Diagnostics Hemoglobin Reagent Set — TECO DIAGNOSTICS · Class II
- SULFOLYSER — Sysmex Corp. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI 6276849c-28e2-4b9e-9550-3069c9a35385 36 fields · synced May 30, 2026