DCA Vantage® Analyzer

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: DCA Vantage® Analyzer FDA UDI
Generic Name: Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
Device Name: The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use. FDA UDI
Model / Reference: 10282969 FDA UDI
Description: The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number: 5075US FDA UDI
Primary DI / UDI-DI: 00630414551364 FDA UDI
510(k) Number: K071466 FDA UDI
FDA Product Code: JIR FDA UDI
CGX FDA UDI
LCP FDA UDI
GMDN Term: Glycated haemoglobin (HbA1C) analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1645 FDA UDI
862.1225 FDA UDI
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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Glycated haemoglobin (HbA1C) analyser IVD

DCA Vantage® Analyzer by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glycated haemoglobin (HbA1C) analyser IVD.

VARIANT II TURBO — Bio-Rad Laboratories · Class I
Glycated Hemoglobin (HbA1C) Analyzer IVD — TOSOH BIOSCIENCE, INC. · Class II
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R — TOSOH BIOSCIENCE, INC. · Class II
D-100 — Bio-Rad Laboratories · Class I
D-10 — Bio-Rad Laboratories · Class I
D-10 — Bio-Rad Laboratories · Class I
Trinity Biotech — Primus Corp. · Class II
ADAMS™ A1c HA-8180V (UL) Analyzer — ARKRAY USA, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 8ed7e58c-500e-437f-af8e-ebab4ae533b8 37 fields · synced May 30, 2026