FDA UDI
In Commercial Distribution
🇺🇸 United States
Diatro•Lyse-5P
DI: 05999883586150
·
Model: D301
·
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diatro•Lyse-5P
- Primary DI
- 05999883586150
- Version / Model
- D301
- Catalog Number
- D3015
- Company Name
- Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
- Labeler DUNS
- 427395277
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 1
- Public Version Date
- 2022-11-30
- Public Version Status
- New
- Public Device Record Key
- 61f389f3-d4bc-4cbe-b45e-6f41480d5147
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | Hematology | 864.8540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61165 | Blood cell lysis reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05999883586150 | GS1 |
Customer Contacts
- Phone
- +3612794400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Liter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 32 Degrees Celsius