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Ansh Labs MenoCheck picoAMH ELISA (IVD)

FDA UDI

by Ansh Labs, LLC

Identity

Trade Name
Ansh Labs MenoCheck picoAMH ELISA (IVD) FDA UDI
Generic Name
Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
AL-124 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
AL-124 FDA UDI
Primary DI / UDI-DI
00853592008127 FDA UDI
GMDN Term
Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

Ansh Labs MenoCheck picoAMH ELISA (IVD) by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ansh Labs, LLC

Sources (1)

  • FDA UDI 41080226-c538-4bdd-b6d0-c9f773d703c7 35 fields · synced May 30, 2026