UF-Fluorocell SF

FDA UDI

Class I (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name: UF-Fluorocell SF FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: UF-Fluorocell SF is used to mark formed elements in urine or in body fluids for determination of red blood cells, casts, etc. counts with the Sysmex fully automated urine particle analyzers. UF-Fluorocell SF is intended for use only in conjunction with Sysmex diluent UF-CELLPACK SF. FDA UDI
Model / Reference: CE919553 FDA UDI
Description: UF-Fluorocell SF is used to mark formed elements in urine or in body fluids for determination of red blood cells, casts, etc. counts with the Sysmex fully automated urine particle analyzers. UF-Fluorocell SF is intended for use only in conjunction with Sysmex diluent UF-CELLPACK SF. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987562433957 FDA UDI
FDA Product Code: GJH FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1850 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 — 29 Milliliter FDA UDI

Category: Buffered sample diluent IVD

UF-Fluorocell SF by Sysmex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Sysmex Corp.

Sources (1)

FDA UDI 9cd7c522-a2d8-499a-9280-6f85c1b55023 36 fields · synced Jun 7, 2026