Ansh Labs Ultrasensitive AMH/MIS ELISA

Basic Information

• Brand Name: Ansh Labs Ultrasensitive AMH/MIS ELISA
• Primary DI: 00853592008004
• Version / Model: AL-105-i
• Catalog Number: AL-105-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: 9317f4dd-dabc-41f3-864b-ebd232396eb7

Device Description

The Ultra-Sensitive Anti-Müllerian hormone/ Müllerian inhibiting substance (US AMH/MIS) enzyme linked immunuosorbent assay (ELISA) kit provides materials for the quantitative measurement of AMH/MIS in human serum, plasma and other biological fluids. This assay is intended for in vitro diagnostic use only.

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
58413	Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) 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	00853592008004	GS1

Customer Contacts

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