Diatro•Dil-5P

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name: Diatro•Dil-5P FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: Diatro•Dil-5P diluent is a buffered, stabilized and micro-filtered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpopulations, thrombocytes (PLT) and measurement of hemoglobin (HGB) concentration on Diatron hematology analyzers. FDA UDI
Model / Reference: D151 FDA UDI
Description: Diatro•Dil-5P diluent is a buffered, stabilized and micro-filtered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpopulations, thrombocytes (PLT) and measurement of hemoglobin (HGB) concentration on Diatron hematology analyzers. FDA UDI

Identifiers

Catalog Number: D1512 FDA UDI
Primary DI / UDI-DI: 05999883586570 FDA UDI
FDA Product Code: GIF FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.8200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 20 Liter FDA UDI

Category: Buffered sample diluent IVD

Diatro•Dil-5P by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class I — FDA UDI — listed…

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Sources (1)

FDA UDI 56507778-376a-45bc-b168-8ac0fb644c08 37 fields · synced May 30, 2026