| Primary Device ID | 05999883586150 |
| NIH Device Record Key | 61f389f3-d4bc-4cbe-b45e-6f41480d5147 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diatro•Lyse-5P |
| Version Model Number | D301 |
| Catalog Number | D3015 |
| Company DUNS | 427395277 |
| Company Name | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com | |
| Phone | +3612794400 |
| support@diatron.com |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05999883586150 [Primary] |
| GGK | Products, Red-Cell Lysing Products |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-30 |
| Device Publish Date | 2022-11-22 |
| 05999883586105 - Diatro•Lyse-DIFF | 2023-05-02 Diatro•Lyse-DIFF lysing reagent is a stabilized and microfiltered lysing agent for stromatolysis of erythtrocytes (RBC), for q |
| 15999883586164 - Diatro•Diff-5P | 2023-05-02 Diatro•Diff-5P WBC differentiation reagent is a stabilized and micro-filtered reagent for quantitative determination of leukoc |
| 15999883586188 - Diatro•Cleaner | 2023-05-02 Diatro•Cleaner cleaning reagent is a stabilized and microfiltered detergent solution for regular automated cleaning, rinsing a |
| 15999883586638 - Diatro•Hypoclean CC | 2023-05-02 Diatro•Hypoclean CC hypochlorite cleaning concentrate is a stabilized and micro-filtered concentrated hypochlorite solution fo |
| 15999883586591 - Additive for wash solution | 2023-05-02 Wash solution additive contains concentrated detergents, for regular cleaning and rinsing of clinical chemistry analyzers’ pro |
| 25999883586611 - Cuvette Cleaner Solutions | 2023-05-02 Cleaning kit contains stabilized and micro-filtered hypochlorite and detergents, for regular cleaning and rinsing of clinical ch |
| 25999883586185 - Diatro•Cleaner | 2023-05-02 Diatro•Cleaner cleaning reagent is a stabilized and microfiltered detergent solution for regular automated cleaning, rinsing a |
| 35999883586588 - Cleaning Solution | 2023-05-02 Cleaning kit contains stabilized and micro-filtered hypochlorite and detergents, for regular cleaning and rinsing of clinical ch |