Ansh Labs PCOCheck ELISA AL-196-i

GUDID 00853592008172

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.

Ansh Labs, LLC

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00853592008172
• NIH Device Record Key: f3fbe163-14a3-4f23-ae3b-2089c97b963a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ansh Labs PCOCheck ELISA
• Version Model Number: AL-196-i
• Catalog Number: AL-196-i
• Company DUNS: 057752914
• Company Name: Ansh Labs, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com
• Phone: (281) 404-0260
• Email: TechSupport@AnshLabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853592008172 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-10
• Device Publish Date: 2021-06-02

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