AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® GLUCOSE REAGENT 88807 (00817302020656)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® GLUCOSE REAGENT 88807
Version or Model: 88807
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88807
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: GLU3 (Glucose) - CX3 Reagent 1 x 500 mL

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?
53301	Glucose IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFR	HEXOKINASE, GLUCOSE

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 2-8° C until expiration date
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days when stored at room temperature (18 - 25° C)
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 500 Milliliter
Device Size Text, specify: Kit contains 1 R1 and 1 package insert

Device Record Status

Public Device Record Key: 8da4e8c6-5bfb-4f6c-89de-8b356f04ee2b
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: September 01, 2016