AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224 (00817302020205)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224
Version or Model: AU-224
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU-224
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: ALB (Albumin) 3 x 250 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 a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of albumin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIX	BROMCRESOL GREEN 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: Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
Special Storage Condition, Specify: After opening, the reagent is stable for 21 days when stored at 2 to 8°
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 00bcba2a-ef8d-48dc-a8f1-5f792d6f91ce
Public Version Date: August 14, 2023
Public Version Number: 4
DI Record Publish Date: September 01, 2016