Diatro•Lyse-DIFF D2011

GUDID 05999883586105

Diatro•Lyse-DIFF lysing reagent is a stabilized and microfiltered lysing agent for stromatolysis of erythtrocytes (RBC), for quantitative determination of leukocytes (WBC), leukocyte three-part differentiation (LYM, MID, GRAN) and hemoglobin (HGB) concentration measurement in human blood on on all WBC-3-part Diatron hematology analyzers.

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Blood cell lysis reagent IVD

• Primary Device ID: 05999883586105
• NIH Device Record Key: 5632c98f-2f9e-4ef7-a46d-23630c1bff89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diatro•Lyse-DIFF
• Version Model Number: D201
• Catalog Number: D2011
• 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

Customer Support Contacts

• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com
• Phone: +3612794400
• Email: support@diatron.com

Device Dimensions

• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter
• Total Volume: 1 Liter

Operating and Storage Conditions

• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05999883586105 [Primary]
GS1	15999883586102 [Package]; Package: Cardboard [6 Units]; In Commercial Distribution

FDA Product Code

• GGK: Products, Red-Cell Lysing Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-02
• Device Publish Date: 2023-04-24

Devices Manufactured by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

• 05999883586105 - Diatro•Lyse-DIFF: 2023-05-02Diatro•Lyse-DIFF lysing reagent is a stabilized and microfiltered lysing agent for stromatolysis of erythtrocytes (RBC), for quantitative determination of leukocytes (WBC), leukocyte three-part differentiation (LYM, MID, GRAN) and hemoglobin (HGB) concentration measurement in human blood on on all WBC-3-part Diatron hematology analyzers.
• 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