Abacus 5 Hematology Analyzer

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Abacus 5 Hematology Analyzer FDA UDI
Generic Name: Haematological cell analyser IVD FDA UDI
Device Name: Abacus 5 is an automated differential cell counter device used to identify one or more of the formed elements of the blood. The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,MCH, MCHC, RDWcv, RDWsd, PCT, PDWcv, PDWsd, PLT, MPV, PLCC, and PLCR. FDA UDI
Model / Reference: Abacus 5 FDA UDI
Description: Abacus 5 is an automated differential cell counter device used to identify one or more of the formed elements of the blood. The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,MCH, MCHC, RDWcv, RDWsd, PCT, PDWcv, PDWsd, PLT, MPV, PLCC, and PLCR. FDA UDI

Identifiers

Catalog Number: A5US-1 FDA UDI
Primary DI / UDI-DI: 05999883586228 FDA UDI
FDA Product Code: GKZ FDA UDI
GMDN Term: Haematological cell analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5220 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Depth — 493 Millimeter FDA UDI
Width — 410 Millimeter FDA UDI
Height — 520 Millimeter FDA UDI

Category: Haematological cell analyser IVD

Abacus 5 Hematology Analyzer by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class II…

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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 II	Pending data

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Manufacturer

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

Sources (1)

FDA UDI d9b7d64a-5fc4-4ef7-a085-3456746ab714 37 fields · synced May 30, 2026