AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218 (00817302024111)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218
Version or Model: AU-240
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AU-240
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302024111
Issuing Agency: GS1
Commercial Distribution End Date: October 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: Alkaline Aminotransferase (ALT) (GPT) Reagent

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?
52923	Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CKA	NADH OXIDATION/NAD REDUCTION, ALT/SGPT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 8 Milliliter
Total Volume: 44 Milliliter
Device Size Text, specify: Kit contains 3 R1 bottles and 3 R2 bottles

Device Record Status

Public Device Record Key: 1f581aff-23b5-4f5f-b8b8-0bde84f8f1d9
Public Version Date: October 17, 2022
Public Version Number: 2
DI Record Publish Date: August 19, 2022