Identity
- Trade Name
- STROMATOLYSER-IM FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- Lysing reagent for analysis of immature WBC FDA UDI
- Model / Reference
- SIM-220A FDA UDI
- Description
- Lysing reagent for analysis of immature WBC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00664369200268 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
Yes
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 — 10 Liter FDA UDI
Category: Blood cell lysis reagent IVD
Stromatolyser-Im by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ZAPR™ — INCELL CORPORATION, LLC · Class I
- Diatro•Diff-5P — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag · 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 f7166fa6-fc20-41f8-af58-6e0c060763a5 36 fields · synced Jun 6, 2026