Identity
- Trade Name
- STROMATOLYSER-4DS FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part differential count with selected Sysmex automated hematology analyzers. FDA UDI
- Model / Reference
- 98417216 FDA UDI
- Description
- STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part differential count with selected Sysmex automated hematology analyzers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562201389 FDA UDI
- FDA Product Code
- GGK FDA UDI
- GMDN Term
- Blood cell lysis reagent IVD 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 — 42 Milliliter FDA UDI
Category: Blood cell lysis reagent IVD
Stromatolyser-4ds by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 90f8db08-6956-4955-817f-146e55986116 36 fields · synced May 30, 2026