Uf-Control

FDA UDI

Class I (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name: UF-CONTROL FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device. FDA UDI
Model / Reference: BE740265 FDA UDI
Description: UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987562433681 FDA UDI
FDA Product Code: JJW FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

Yes

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 — 30 Milliliter FDA UDI

Category: Buffered sample diluent IVD

Uf-Control by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Lumipulse G Specimen Diluent 2 — FUJIREBIO INC. · Class I
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IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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: Sysmex Corp.

Sources (1)

FDA UDI 3cae698d-e366-4486-bccb-1c223392e5e3 36 fields · synced May 30, 2026