Ansh Labs PCOCheck ELISA

Basic Information

• Brand Name: Ansh Labs PCOCheck ELISA
• Primary DI: 00853592008172
• Version / Model: AL-196-i
• Catalog Number: AL-196-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: f3fbe163-14a3-4f23-ae3b-2089c97b963a

Device Description

The PCOCheck ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH) in human serum, Li-Heparin and K2 EDTA plasma. This assay is not impacted by AMH post translational modifications. It is intended to be used as an aid in the determination of ovarian reserve, and stratification of women with polycystic ovarian morphology (PCOM). 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
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	00853592008172	GS1

Customer Contacts

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