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 ID00853592008288
NIH Device Record Keyd2a91fc8-5f53-4039-9f8b-d68447bfb880
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnsh Labs Unconjugated Estriol EIA
Version Model NumberAL-138-i
Catalog NumberAL-138-i
Company DUNS057752914
Company NameAnsh Labs, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM
Phone281-404-0260
EmailTECHSUPPORT@ANSHLABS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100853592008288 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

On-Brand Devices [Ansh Labs Unconjugated Estriol EIA]

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