Caldon Biotech Serum Aldolase Controls

Basic Information

• Brand Name: Caldon Biotech Serum Aldolase Controls
• Primary DI: 00817302024661
• Version / Model: COAL-015
• Catalog Number: COAL-015
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: e33f5eeb-f512-473b-b02a-3344db1a6dfc

Device Description

Aldolase Controls

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45826	Aldolase IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of aldolase in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302024661	GS1

Customer Contacts

• Phone: [phone] ext. 21340
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	2	Milliliter
Device Size Text, specify			Kit contains 2 R1 bottles and 2 R2 bottles

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius