AccessGUDID - DEVICE: POINTE SCIENTIFIC CRP Control Set (00811727011060)

GUDID

Device Identifier (DI) Information

Brand Name: POINTE SCIENTIFIC CRP Control Set
Version or Model: C7568-CTL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7568-CTL
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727011060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: These C-Reactive Protein Controls are intended for use in C-Reactive Protein (High Sensitivity) Wide Range test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only.

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):	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?
41839	C-reactive protein (CRP) IVD, control	A material which is used to verify the performance of an assay intended to be 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 [?]
K002651	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: 3b11bf4d-05ee-4b29-9183-934cf84417ba
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: August 31, 2016