CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263

Basic Information

• Brand Name: CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263
• Primary DI: 00817302024029
• Version / Model: 100263
• Catalog Number: 100263
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-06
• Public Version: 1
• Public Version Date: 2022-07-14
• Public Version Status: New
• Public Device Record Key: 71e9b6d5-5f63-46ab-8aa0-9f8a596f01bf

Device Description

Alkaline Wash Solution (ALK)

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
JCB	DETERGENT	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302024029	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Kit contains 2 R1 bottles
Total Volume	500	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 30 Degrees Celsius