AccessGUDID - DEVICE: ADVIA® Chemistry CREA_2 Creatinine Reagents (00630414517490)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry CREA_2 Creatinine Reagents
Version or Model: 10309050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3039070
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414517490
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Creatinine Jaffe - ADVIA Chem. - RGT - 6x670 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
CGX	ALKALINE PICRATE, COLORIMETRY, CREATININE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991576	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
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: efc52dd7-b038-4663-8939-a15b8903cff2
Public Version Date: December 20, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016