AccessGUDID - DEVICE: DImension Vista® Apolipoprotein Control (00842768006371)

GUDID

Device Identifier (DI) Information

Brand Name: DImension Vista® Apolipoprotein Control
Version or Model: 10445923
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KC725
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768006371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: APO CON is an assayed intralaboratory quality control for the assessment of precision and analytical bias in the determination of APOAI and APOB methods on the Dimension Vista® System

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?
30506	Plasma protein IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063608	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7edd9e3c-9756-4d5e-85ec-b2abd2b2a30c
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020