Ansh Labs AnshCheck AMH Tri-Level Controls

Basic Information

• Brand Name: Ansh Labs AnshCheck AMH Tri-Level Controls
• Primary DI: 00853592008103
• Version / Model: AL-CTR-401-i
• Catalog Number: AL-CTR-401-i
• Company Name: Ansh Labs, LLC
• Labeler DUNS: 057752914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-03
• Public Version: 1
• Public Version Date: 2021-06-11
• Public Version Status: New
• Public Device Record Key: 33c433ef-7f01-4940-82e4-0d6112a6f0c0

Device Description

Ansh Labs AMH Tri-Level Controls are intended for use as assay quality controls to monitor the precision and reproducibility of laboratory testing methods for the determination of AMH in serum, plasma or other biological fluids. Tri-level controls are run as unknowns against kit calibrators in any human AMH assays.

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: 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	00853592008103	GS1

Customer Contacts

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