AccessGUDID - DEVICE: Atellica CH CRP

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH CRP_2
Version or Model: 11097631
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11097631
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414596198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: C-Reactive Protein_2 (CRP_2) Atellica CH - RGT 1000T

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?
53705	C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCN	SYSTEM, TEST, C-REACTIVE PROTEIN
DCK	C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1b115eb-756c-47e4-9f8a-28430fdee6a7
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: December 27, 2017