Ansh Labs Inhibin A ELISA AL-123-i

GUDID 00853592008073

The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human 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 Inhibin A in combination with hAFP, hCG, and uE3 measurements.

Ansh Labs, LLC

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Primary Device ID00853592008073
NIH Device Record Keyc48c8716-a494-40d8-a826-a3e8fb2e47c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnsh Labs Inhibin A ELISA
Version Model NumberAL-123-i
Catalog NumberAL-123-i
Company DUNS057752914
Company NameAnsh Labs, LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com
Phone(281) 404-0260
EmailTechSupport@AnshLabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853592008073 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

On-Brand Devices [Ansh Labs Inhibin A ELISA]

00853592008097The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitat
00853592008073The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitat

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