Ansh Labs Unconjugated Estriol EIA

Primary DI
00853592008288
Brand
Ansh Labs Unconjugated Estriol EIA
Company
Ansh Labs, LLC
Model
AL-138-i
Catalog number
AL-138-i
Device 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.
Published
2024-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853592008288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853592008288008535920082888535920082880853592008288

GMDN Terms#

Term, Definition table
TermDefinition
Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically measured in maternal blood, urine or saliva as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
281-404-0260TECHSUPPORT@ANSHLABS.COM

Regulatory Flags#

DUNS number
057752914
Device count
1
Kit
true
Lot or batch
true

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Primary DI, Brand, Model table
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