AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 (00817302020946)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214
Version or Model: AU-214
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU-214
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020946
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: ALB (Albumin) BCP 3 x 275 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:	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?
53599	Albumin IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of albumin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CJW	BROMCRESOL PURPLE DYE-BINDING, ALBUMIN

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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 25 Milliliter
Device Size Text, specify: Kit contains 3 R1 bottles and 1 package insert
Total Volume: 60 Milliliter

Device Record Status

Public Device Record Key: 25fc4cc4-6649-41fb-8869-adb98ee71060
Public Version Date: August 18, 2025
Public Version Number: 3
DI Record Publish Date: September 01, 2016