Ansh Labs MenoCheck picoAMH ELISA (IVD) AL-124

GUDID 00853592008127

The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only.

Ansh Labs, LLC

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Primary Device ID00853592008127
NIH Device Record Key41080226-c538-4bdd-b6d0-c9f773d703c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnsh Labs MenoCheck picoAMH ELISA (IVD)
Version Model NumberAL-124
Catalog NumberAL-124
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 Perscriptiontrue
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
GS100853592008127 [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

Devices Manufactured by Ansh Labs, LLC

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