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Ansh Labs, LLC

Last updated September 17, 2026

Information

Country: US
Address: 445 Medical Center Blvd, Webster, TX, 77598
Website: anshlabs.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (281) 404-0260
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008198807
DUNS Number: 057752914

Catalogue (34)

Device	Model / Reference	Registries	Class	Status
Ansh Labs Activin A ELISA	AL-110-i	FDA UDI	N/A	Active
Ansh Labs Ultrasensitive AMH/MIS ELISA	AL-105-i	FDA UDI	N/A	Active
Ansh Labs picoAMH ELISA	AL-124-i	FDA UDI	N/A	Active
Ansh Labs US Follicle-stimulating Hormone ELISA	AL-186	FDA UDI	N/A	Active
Ansh Labs DBS Luteinizing Hormone ELISA	AL-190-i	FDA UDI	N/A	Active
Ansh Labs Inhibin A ELISA	AL-123-i	FDA UDI	N/A	Active
Ansh Labs MenoCheck picoAMH ELISA (IVD)	AL-124	FDA UDI	N/A	Active
Ansh Labs Ultra-Sensitive Luteinizing Hormone ELISA	AL-188	FDA UDI	N/A	Active
Ansh Labs picoPAPP-A ELISA (CE)	AL-101-i	FDA UDI	N/A	Active
Ansh Labs Inhibin A ELISA	AL-123	FDA UDI	N/A	Active
Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA	AL-1016-i	FDA UDI	N/A	Active
Ansh Labs Follistatin ELISA	AL-117-i	FDA UDI	N/A	Active
Ansh Labs Prolactin ELISA (IVD)	AL-199	FDA UDI	N/A	Active
Ansh Labs Total IGF-I ELISA (IVD)	AL-121	FDA UDI	N/A	Active
Ansh Labs AnshCheck AMH Tri-Level Controls	AL-CTR-401-i	FDA UDI	N/A	Active
Ansh Labs Dried Blood Spot (DBS) AMH ELISA	AL-129-i	FDA UDI	N/A	Active
Ansh Labs C-Peptide ELISA	AL-151-i	FDA UDI	N/A	Active
Ansh Labs PECheck(TM) PAPP-A2 ELISA	AL-1015-i	FDA UDI	N/A	Active
Ansh Labs PAPP-A2 ELISA	AL-109-i	FDA UDI	N/A	Active
Ansh Labs Glucagon ELISA	AL-157	FDA UDI	N/A	Active
Ansh Labs PLGF ELISA	AL-1008-i	FDA UDI	N/A	Active
Ansh Labs PAPP-A ELISA (CE)	AL-106-i	FDA UDI	N/A	Active
Papp-A Elisa (ce)	AL-106-4-i	FDA UDI	N/A	Active
Ansh Labs Glycosylated Fibronectin ELISA	AL-160-i	FDA UDI	N/A	Active
Ansh Labs Total IGF-I ELISA (CE)	AL-121-i	FDA UDI	N/A	Active
Ansh Labs PCOCheck ELISA	AL-196-i	FDA UDI	N/A	Active
Ansh Labs Ultrasensitive Inhibin B ELISA	AL-195-i	FDA UDI	N/A	Active
Ansh Labs Inhibin B ELISA (CE)	AL-107-i	FDA UDI	N/A	Active
Ansh Labs Unconjugated Estriol EIA	AL-138-i	FDA UDI	N/A	Active
Ansh Labs Unconjugated Estriol EIA	AL-138	FDA UDI	N/A	Active
Ansh Labs Prolactin ELISA (CE)	AL-199-i	FDA UDI	N/A	Active
Ansh Labs DBS Follicle-Stimulating Hormone ELISA	AL-187-i	FDA UDI	N/A	Active
Ansh Labs Glucagon ELISA	AL-157-i	FDA UDI	N/A	Active
picoAMH ELISA	DEN180004	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 18, 2020	Z-0842-2021	—	terminated	Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to remove Plasma as a "sample type" and to update the "limitation" section to include potential cross-reactivity with non-SARS-CoV2 strains.