DCA™ Systems Hemoglobin A1c Control Kit

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: DCA™ Systems Hemoglobin A1c Control Kit FDA UDI
Generic Name: Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Device Name: The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL Controls which are prepared as a stabilized hemolysate from human blood. The DCA Hemoglobin A1c Control Kit has been designed for use with DCA™ Analyzers. FDA UDI
Model / Reference: 10311161 FDA UDI
Description: The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL Controls which are prepared as a stabilized hemolysate from human blood. The DCA Hemoglobin A1c Control Kit has been designed for use with DCA™ Analyzers. FDA UDI

Identifiers

Catalog Number: 5068A FDA UDI
Primary DI / UDI-DI: 00630414497105 FDA UDI
FDA Product Code: LCP FDA UDI
GMDN Term: Glycated haemoglobin (HbA1c) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7470 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glycated haemoglobin (HbA1c) IVD, control

DCA™ Systems Hemoglobin A1c Control Kit by Siemens Healthcare Diagnostics — 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: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 9131bbd9-3b70-4e8d-a435-96202b5eca1f 36 fields · synced May 30, 2026