Diatro•Diff-5P D3021

GUDID 15999883586164

Diatro•Diff-5P WBC differentiation reagent is a stabilized and micro-filtered reagent for quantitative determination of leukocytes (WBC) and leukocyte 5-part differentiation (LYM, MONO, NEU, EO, BA) measurement in human blood on Diatron Abacus 5 hematology analyzers.

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD

• Primary Device ID: 15999883586164
• NIH Device Record Key: 2d7084f7-cd9c-4ad9-9f54-9979f8d02016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diatro•Diff-5P
• Version Model Number: D302
• Catalog Number: D3021
• 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	05999883586167 [Primary]
GS1	15999883586164 [Package]; Contains: 05999883586167; 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

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