Ansh Labs Unconjugated Estriol EIA AL-138-i

GUDID 00853592008288

The Unconjugated Estriol (uE3) Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated estriol in serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Down syndrome (Trisomy 21) screening in the 2nd trimester using combined biochemical and ultrasound markers may be assessed with appropriate risk calculation software.1,2 It is strongly recommended to use validated software (CE marked) designated specifically for evaluating the risk of Trisomy 21 using uE3 in combination with AFP, hCG, and Inhibin A measurements.

Ansh Labs, LLC

Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00853592008288
• NIH Device Record Key: d2a91fc8-5f53-4039-9f8b-d68447bfb880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ansh Labs Unconjugated Estriol EIA
• Version Model Number: AL-138-i
• Catalog Number: AL-138-i
• Company DUNS: 057752914
• Company Name: Ansh Labs, LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• Phone: 281-404-0260
• Email: TECHSUPPORT@ANSHLABS.COM
• Phone: 281-404-0260
• Email: TECHSUPPORT@ANSHLABS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853592008288 [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: 2024-08-20
• Device Publish Date: 2024-08-12

On-Brand Devices [Ansh Labs Unconjugated Estriol EIA]

• 00853592008271: The Unconjugated Estriol Enzyme Immunoassay (EIA) Kit provides materials for the quantitative me
• 00853592008288: The Unconjugated Estriol (uE3) Enzyme Immunoassay (EIA) Kit provides materials for the quantitat