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Ansh Labs PCOCheck ELISA

FDA UDI

by Ansh Labs, LLC

Identity

Trade Name
Ansh Labs PCOCheck ELISA FDA UDI
Generic Name
Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
AL-196-i FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
AL-196-i FDA UDI
Primary DI / UDI-DI
00853592008172 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

No

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 PCOCheck ELISA 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 f3fbe163-14a3-4f23-ae3b-2089c97b963a 35 fields · synced May 31, 2026