Identity
- Trade Name
- LYSERCELL WDF FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF FDA UDI
- Model / Reference
- AZ124801 FDA UDI
- Description
- Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562499809 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 — 2 Liter FDA UDI
Category: Blood cell lysis reagent IVD
Lysercell Wdf by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood cell lysis reagent IVD.
- ADVIA® 360 Lyse 3P Diff — Siemens Healthcare Diagnostics · Class II
- ADVIA® 560 Lyse — Siemens Healthcare Diagnostics · Class II
- ZAPR™ — INCELL CORPORATION, LLC · Class I
- Diatro•Lyse-5P — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag · Class I
- MINILYSEBIO (1L) — Horiba Abx · Class I
- Diatro•Lyse-DIFF — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI f86b474a-b84f-4acf-8192-5e06c89493ba 36 fields · synced Jun 1, 2026