Xn Cal

FDA UDI

Class II (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name: XN CAL FDA UDI
Generic Name: Full blood count IVD, calibrator FDA UDI
Device Name: XN CAL 5X3.0ML FDA UDI
Model / Reference: 213528 FDA UDI
Description: XN CAL 5X3.0ML FDA UDI

Identifiers

Primary DI / UDI-DI: 14987562460332 FDA UDI
FDA Product Code: KRX FDA UDI
GMDN Term: Full blood count IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.8150 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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 — 3 Milliliter FDA UDI

Category: Full blood count IVD, calibrator

Xn Cal by Sysmex Corp. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Sysmex Corp.

Sources (1)

FDA UDI 044f6a73-1c66-41b9-abee-382a25aa2da3 36 fields · synced May 30, 2026