AccessGUDID - DEVICE: Caldon Biotech Aldolase Reagent (00817302024654)

GUDID

Device Identifier (DI) Information

Brand Name: Caldon Biotech Aldolase Reagent
Version or Model: CALD-015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CALD-015
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302024654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: Aldolase

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?
52927	Aldolase 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 aldolase in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CJC	FRUCTOSE-1, 6-DIPHOSPHATE AND NADH (U.V.), ALDOLASE

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: 15 Milliliter
Device Size Text, specify: Kit contains 10 R1 bottles

Device Record Status

Public Device Record Key: 116442a3-512f-4411-9896-ea3f8a9314fa
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022