AccessGUDID - DEVICE: DCA Vantage® Analyzer (00630414551364)

GUDID

Device Identifier (DI) Information

Brand Name: DCA Vantage® Analyzer
Version or Model: 10282969
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5075US
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414551364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35968	Glycated haemoglobin (HbA1C) analyser IVD	A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
CGX	ALKALINE PICRATE, COLORIMETRY, CREATININE
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071466	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Max 95% RH at 45'c
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ed7e58c-500e-437f-af8e-ebab4ae533b8
Public Version Date: November 19, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016