AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.™ DBIL DIRECT BILIRUBIN REAGENT CC229 (00817302020601)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ DBIL DIRECT BILIRUBIN REAGENT CC229
Version or Model: CC229
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CC229
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020601
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: DBIL (Direct Bilirubin) 2 x 200 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?
53232	Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	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 when stored at 8-30° C until expiration date
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2 reagent cartridges and 1 package insert
Total Volume: 8 Milliliter
Total Volume: 75 Milliliter

Device Record Status

Public Device Record Key: fa761577-c9a2-48b8-b1d8-d051c6663532
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016