Ca Cal S

FDA UDI

Class II (US FDA UDI)

by Sysmex Corp.

Identity

Trade Name: CA CAL S FDA UDI
Generic Name: Multiple coagulation factor IVD, calibrator FDA UDI
Device Name: CA CAL S 3.0X3 (GCL-100A) FDA UDI
Model / Reference: 01412714 FDA UDI
Description: CA CAL S 3.0X3 (GCL-100A) FDA UDI

Identifiers

Primary DI / UDI-DI: 04987562205936 FDA UDI
FDA Product Code: GKP FDA UDI
GMDN Term: Multiple coagulation factor IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5400 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple coagulation factor IVD, calibrator

Ca Cal S 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 e7da359e-4871-4002-b86d-70f39f21ec8a 34 fields · synced Jun 8, 2026