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

• 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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