AccessGUDID - DEVICE: CRP (05055273201642)

GUDID

Device Identifier (DI) Information

Brand Name: CRP
Version or Model: CP1423
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP1423
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273201642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The device is a latex agglutination slide test intended for qualitative and semi-quantitative in vitro diagnostic determination of C-Reactive Protein (CRP) concentration 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 [?]
K954447	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: Must reach room temperature before use. Do not freeze any of the reagents.
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: bfed086f-e6a7-4d80-9d12-e6668adddfe2
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 16, 2016