AccessGUDID - DEVICE: K-CHECK CONTROLS (00860009154025)

GUDID

Device Identifier (DI) Information

Brand Name: K-CHECK CONTROLS
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B1777
Company Name: Biorex Labs LLC

Primary DI Number: 00860009154025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060975106 *Terms of Use

Device Description: The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year.

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):	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?
55470	Acetone 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 acetone in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Refrigerate between 2-10 degrees Celsius (°C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c08d985-5e2e-4197-8bc9-17d3ff57da6c
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022