Device
Atellica CH Creatinine (Crea3) Reagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc.
Model: 11537215
Catalog: 11537215
DI: 00630414611075
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Atellica CH Creatinine (Crea3) Reagent
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1cf1bdcb-9eb2-4aab-b8ac-0ffd9d8427ed
Distribution Status:
In Commercial Distribution
DUNS Number:
064608573
Device Count:
4
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00630414305103
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00630414611075
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 53251
Name: Creatinine IVD, kit, spectrophotometry
Definition:
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.
FDA Product Codes
CGX
ALKALINE PICRATE, COLORIMETRY, CREATININE
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
8
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
2
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
8
Item #2 - Storage Handling Type:
Storage Environment Temperature