Ansh Labs Ultrasensitive Inhibin B ELISA

Basic Information

• Brand Name: Ansh Labs Ultrasensitive Inhibin B ELISA
• Primary DI: 00853592008165
• Version / Model: AL-195-i
• Catalog Number: AL-195-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: 027889a2-1e9d-4193-846f-f61229d8357e

Device Description

The US Inhibin B enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Inhibin B in human serum and other biological fluids. 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
54233	Inhibin B IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of inhibin B 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	00853592008165	GS1

Customer Contacts

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