Fecal Extraction Device

Basic Information

• Brand Name: Fecal Extraction Device
• Primary DI: 08426950846833
• Version / Model: 504837
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-30
• Public Version: 5
• Public Version Date: 2023-10-16
• Public Version Status: Update
• Public Device Record Key: 7c7c3833-a787-40b6-893d-29f8acfbed1b

Device Description

-100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps

Device Characteristics

• Single Use: Yes
• 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: No
• 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
NXO	Calprotectin, Fecal	Immunology	866.5180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62675	Calprotectin IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen, using a chemiluminescent immunoassay method. This test is commonly used to aid in the diagnosis of inflammatory bowel disease or other causes of intestinal inflammation.	No	Active
52862	Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with gastrointestinal disease in a clinical specimen, using an enzyme immunoassay (EIA) method. Markers to be assayed may include pepsinogen I, pepsinogen II, gastrin and/or antibodies to the bacteria Helicobacter pylori.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950846833	GS1

Customer Contacts

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

Storage Conditions

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