Ansh Labs Glycosylated Fibronectin ELISA

Basic Information

• Brand Name: Ansh Labs Glycosylated Fibronectin ELISA
• Primary DI: 00853592008110
• Version / Model: AL-160-i
• Catalog Number: AL-160-i
• Company Name: Ansh Labs, LLC
• Labeler DUNS: 057752914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-02
• Public Version: 1
• Public Version Date: 2021-06-10
• Public Version Status: New
• Public Device Record Key: 1f57ff50-920a-4319-88e6-9026552fc85a

Device Description

Glycosylated Fibronectin enzyme linked immunoassay (ELISA) kit provides the materials for the quantitative measurement of GlyFn in human maternal serum. This assay is intended for in vitro diagnostic use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
53720	Fibronectin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of fibronectin in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853592008110	GS1

Customer Contacts

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