AccessGUDID - DEVICE: ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) (00630414526690)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic)
Version or Model: 10335869
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4992596
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414526690
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Creatinine enzymatic - ADVIA Chem. - RGT - 4x350 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?
53251	Creatinine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFY	ENZYMATIC METHOD, CREATININE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070727	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
Special Storage Condition, Specify: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 76c1301b-0206-4a16-837f-0f4183abf807
Public Version Date: February 13, 2025
Public Version Number: 8
DI Record Publish Date: September 24, 2016