AccessGUDID - DEVICE: ADVIA® Chemistry UPRO_2 Total Protein

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry UPRO_2 Total Protein_2 (Urine) Reagents
Version or Model: 10335885
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5000171
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414526782
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2023
Device Count: 4
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Protein - ADVIA Chem. - RGT - 4x194 tests

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?
53985	Total protein IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CEK	BIURET (COLORIMETRIC), TOTAL PROTEIN

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
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c8019be-fa5c-4100-8238-3682138df57d
Public Version Date: June 06, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016