Ansh Labs PCOCheck ELISA AL-196-i

GUDID 00853592008172

The PCOCheck ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH) in human serum, Li-Heparin and K2 EDTA plasma. This assay is not impacted by AMH post translational modifications. It is intended to be used as an aid in the determination of ovarian reserve, and stratification of women with polycystic ovarian morphology (PCOM). This assay is intended for in vitro diagnostic use.

Ansh Labs, LLC

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00853592008172
NIH Device Record Keyf3fbe163-14a3-4f23-ae3b-2089c97b963a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnsh Labs PCOCheck ELISA
Version Model NumberAL-196-i
Catalog NumberAL-196-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
GS100853592008172 [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

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