Diatro•Diff-5P

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name: Diatro•Diff-5P FDA UDI
Generic Name: Blood cell lysis reagent IVD FDA UDI
Device Name: 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. FDA UDI
Model / Reference: D302 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: D3021 FDA UDI
Primary DI / UDI-DI: 05999883586167 FDA UDI
FDA Product Code: GGK FDA UDI
GMDN Term: Blood cell lysis reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.8540 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 — 1 Liter FDA UDI

Category: Blood cell lysis reagent IVD

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

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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 2d7084f7-cd9c-4ad9-9f54-9979f8d02016 37 fields · synced May 30, 2026