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Ansh Labs Unconjugated Estriol EIA

FDA UDI

by Ansh Labs, LLC

Identity

Trade Name
Ansh Labs Unconjugated Estriol EIA FDA UDI
Generic Name
Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
AL-138-i FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
AL-138-i FDA UDI
Primary DI / UDI-DI
00853592008288 FDA UDI
GMDN Term
Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Ansh Labs Unconjugated Estriol EIA by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ansh Labs, LLC

Sources (1)

  • FDA UDI d2a91fc8-5f53-4039-9f8b-d68447bfb880 35 fields · synced Jun 1, 2026