EasyLyse Erythrocyte-Lysing Reagent

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Singapore Pte Ltd

Identity

Trade Name: EasyLyse Erythrocyte-Lysing Reagent FDA UDI
Generic Name: Blood cell lysis reagent IVD FDA UDI
Device Name: EasyLyse Erythrocyte-Lysing Reagent FDA UDI
Model / Reference: S2364 FDA UDI
Description: EasyLyse Erythrocyte-Lysing Reagent FDA UDI

Identifiers

Primary DI / UDI-DI: 05700571112748 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 — 5 Milliliter FDA UDI

Category: Blood cell lysis reagent IVD

EasyLyse Erythrocyte-Lysing Reagent by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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STROMATOLYSER-4DS — Sysmex Corp. · Class I
STROMATOLYSER-FB — Sysmex Corp. · Class I

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: Agilent Technologies Singapore Pte Ltd

Sources (1)

FDA UDI 8756698b-2a83-4f33-9ed6-2a807907baaa 36 fields · synced Jun 8, 2026