AccessGUDID - DEVICE: LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) (05055273216837)

GUDID

Device Identifier (DI) Information

Brand Name: LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)
Version or Model: BR10443
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BR10443
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273216837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.

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?
30215	Total bilirubin IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total bilirubin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

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
Storage Environment Temperature: between -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3821cfa9-45d7-4d38-ad7b-aabc3915f4f3
Public Version Date: September 28, 2022
Public Version Number: 1
DI Record Publish Date: September 20, 2022