AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.™ TBIL TOTAL BILIRUBIN REAGENT CC228 (00817302020717)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ TBIL TOTAL BILIRUBIN REAGENT CC228
Version or Model: CC228
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC228
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020717
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: TBIL (Total Bilirubin) 2 x 300 tests

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:	Yes
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?
53229	Total bilirubin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIG	DIAZO COLORIMETRY, BILIRUBIN

FDA Premarket Submission

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

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: Reagent is stable on board a clinical analyzer for 30 days
Special Storage Condition, Specify: Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2 reagent cartridges filled with reagents R1, R2 & R3 and 1 package inser
Total Volume: 11 Milliliter
Total Volume: 2 Milliliter
Total Volume: 90 Milliliter

Device Record Status

Public Device Record Key: 3fdfa200-4a01-47aa-89c0-aabfe7baaf7a
Public Version Date: August 14, 2023
Public Version Number: 3
DI Record Publish Date: September 01, 2016