Identity
- Trade Name
- Diatro•Lyse-5P FDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- Diatro•Lyse-5P lysing reagent is a stabilized and micro-filtered lysing agent for stromatolysis of erythtrocytes (RBC), for quantitative determination of leukocytes (WBC), leukocyte 5-part differentiation (LYM, MONO, NEU, EO, BA) and hemoglobin (HGB) concentration measurement in human blood on Diatron Abacus 5 hematology analyzers. FDA UDI
- Model / Reference
- D301 FDA UDI
- Description
- Diatro•Lyse-5P lysing reagent is a stabilized and micro-filtered lysing agent for stromatolysis of erythtrocytes (RBC), for quantitative determination of leukocytes (WBC), leukocyte 5-part differentiation (LYM, MONO, NEU, EO, BA) and hemoglobin (HGB) concentration measurement in human blood on Diatron Abacus 5 hematology analyzers. FDA UDI
Identifiers
- Catalog Number
- D3015 FDA UDI
- Primary DI / UDI-DI
- 05999883586150 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
No
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 — 5 Liter FDA UDI
Category: Blood cell lysis reagent IVD
Diatro•Lyse-5P by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class I — FDA UDI…
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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
Sources (1)
- FDA UDI 61f389f3-d4bc-4cbe-b45e-6f41480d5147 37 fields · synced Jun 1, 2026