Ansh Labs picoAMH ELISA AL-124-i

GUDID 00853592008080

The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum, Li-Heparin and K2 EDTA plasma. It is intended to be used as an aid in the determination of ovarian status in women in reproductive age and during menopausal transition. It is intended for in vitro diagnostic use.

Ansh Labs, LLC

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• Primary Device ID: 00853592008080
• NIH Device Record Key: 0041388e-c585-4352-8ae6-80afe1b5a4b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ansh Labs picoAMH ELISA
• Version Model Number: AL-124-i
• Catalog Number: AL-124-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	00853592008080 [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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• 00853592008080 - Ansh Labs picoAMH ELISA: 2021-06-10The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum, Li-Heparin and K2 EDTA plasma. It is intended to be used as an aid in the determination of ovarian status in women in reproductive age and during menopausal transition. It is intended for in vitro diagnostic use.
• 00853592008080 - Ansh Labs picoAMH ELISA: 2021-06-10 The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (A