AccessGUDID - DEVICE: DImension Vista® Immunoglobulin E Flex® reagent cartridge (00842768006173)

GUDID

Device Identifier (DI) Information

Brand Name: DImension Vista® Immunoglobulin E Flex® reagent cartridge
Version or Model: 10445902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K7054
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768006173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) 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?
61274	Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DGC	IGE, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063425	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: 8f64b2d0-017c-4ed7-93a0-9af4964283e8
Public Version Date: August 03, 2023
Public Version Number: 7
DI Record Publish Date: September 24, 2016