AccessGUDID - DEVICE: Dimension Vista® a1-Microglobulin Flex® reagent cartridge (00842768005978)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® a1-Microglobulin Flex® reagent cartridge
Version or Model: 10445882
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K7010
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768005978
Issuing Agency: GS1
Commercial Distribution End Date: September 27, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For the quantitative measurement of a1-microglobulin in human urine 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?
53923	Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-microglobulin in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCO	ALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 747e227d-00f4-4ab7-b5e3-62761e0284c3
Public Version Date: December 06, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2020