Skip to content

Ansh Labs

United States US-MF-000054510 Last updated 17 Sep 2026

Is this your brand? Sign in to claim this brand

Devices
41
Registries
EUDAMEDGUDID
FDA recalls
0

Catalogue41

About

Ansh Labs excels at developing and manufacturing validated immunoassays ELISA for biomedical research and clinical diagnostics.

From the manufacturer's own website. Source

What Ansh Labs makes

Ansh Labs manufactures immunoassay kits for research and clinical diagnostics, including enzyme-linked immunosorbent assays (ELISA) for biomarkers such as inhibin B, anti-Müllerian hormone (AMH), estriol, and placental growth factor (PLGF). These assays are designed for quantitative detection in dried blood spot (DBS) and serum/plasma samples, supporting fertility diagnostics, endocrinology, and reproductive health research. Some products are also configured for use in dried blood spot testing, expanding applicability to paediatric and non-invasive sampling.

The company’s portfolio is regulated under EU In Vitro Diagnostic Regulation (IVDR) categories, including IVD Annex II List B and IVD General devices, with select products listed in the EU’s eudamed registry. These assays are intended for use across biomedical research and clinical settings, adhering to EU compliance requirements for diagnostic accuracy and safety. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
455, W. Medical Center Blvd, Webster, United States
Phone
+1 832 260 0618
PRRC contact
Danielle Kempa
EUDAMED SRN
US-MF-000054510