AccessGUDID - DEVICE: DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin (00842768006098)

GUDID

Device Identifier (DI) Information

Brand Name: DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin
Version or Model: 10445894
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K7034
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768006098
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 albumin in human serum and plasma and cerebrospinal fluid (CSF) 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?
53596	Albumin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a nephelometry/turbidimetry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCF	ALBUMIN, 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: c2b41eae-d663-4745-93d1-4d9f62e20f6f
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016