AccessGUDID - DEVICE: Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set (00817302020045)

GUDID

Device Identifier (DI) Information

Brand Name: Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set
Version or Model: BL243
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BL243
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use
Previous DI: 00817302020052

Device Description: CREA (Creatinine)

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?
53251	Creatinine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (specified) analyte controls (assayed and unassayed)
JFY	ENZYMATIC METHOD, CREATININE

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 reagents are stable to expiration date with stored at 2 to 8°C
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 3 R1, 3 R2 & 1 package insert
Total Volume: 25 Milliliter
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 7ab1120f-b712-41b2-9a48-8091be381fe6
Public Version Date: August 29, 2023
Public Version Number: 4
DI Record Publish Date: September 01, 2016