Ansh Labs picoAMH ELISA AL-124-i

GUDID 00853592008080

The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum, Li-Heparin and K2 EDTA plasma. It is intended to be used as an aid in the determination of ovarian status in women in reproductive age and during menopausal transition. It is intended for in vitro diagnostic use.

Ansh Labs, LLC

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Primary Device ID00853592008080
NIH Device Record Key0041388e-c585-4352-8ae6-80afe1b5a4b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnsh Labs picoAMH ELISA
Version Model NumberAL-124-i
Catalog NumberAL-124-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
GS100853592008080 [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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00853592008080 - Ansh Labs picoAMH ELISA2021-06-10The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum, Li-Heparin and K2 EDTA plasma. It is intended to be used as an aid in the determination of ovarian status in women in reproductive age and during menopausal transition. It is intended for in vitro diagnostic use.
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