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Ansh Labs picoPAPP-A ELISA (CE)

FDA UDI

by Ansh Labs, LLC

Identity

Trade Name
Ansh Labs picoPAPP-A ELISA (CE) FDA UDI
Generic Name
Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The picoPAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in human serum and other biological fluids. This assay is intended for in vitro diagnostic use. FDA UDI
Model / Reference
AL-101-i FDA UDI
Description
The picoPAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in human serum and other biological fluids. This assay is intended for in vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
AL-101-i FDA UDI
Primary DI / UDI-DI
00853592008011 FDA UDI
GMDN Term
Trisomy 21-risk hormone 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: Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)

Ansh Labs picoPAPP-A ELISA (CE) by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trisomy 21-risk hormone 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 23eb308c-b468-4fef-b6fb-92a7756a5f87 35 fields · synced Jun 8, 2026