AccessGUDID - DEVICE: CRP (05055273201758)

GUDID

Device Identifier (DI) Information

Brand Name: CRP
Version or Model: CP2852
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP2852
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273201758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The XCRP method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in serum.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
53707	C-reactive protein (CRP) IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCK	C-Reactive Protein, Antigen, Antiserum, And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953212	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cca876e-41f6-4e4e-ac7e-99369d9443e7
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 16, 2016