CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 20885380096744
• Version / Model: CH6870
• Catalog Number: CH6870
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-12-27
• Public Version: 3
• Public Version Date: 2022-08-29
• Public Version Status: Update
• Public Device Record Key: 85ecf88a-0bde-485d-b32d-54c03129e42e

Device Description

Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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
JTR	KIT, QUALITY CONTROL FOR CULTURE MEDIA	Microbiology	866.2480	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47358	Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple faecal parasites (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380096745	GS1	CASE	64	In Commercial Distribution
Primary	20885380096744	GS1
Unit of Use	10885380096747	GS1

Customer Contacts

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

Storage Conditions

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