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Ansh Labs, LLC: FDA-registered device maker in Webster, TX, United States, 1 510(k) clearance

Name: Ansh Labs, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ansh Labs, LLC is registered with the FDA (registration 3008198807) in Webster, TX, United States. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008198807
Address: 445 Medical Center Blvd, Webster, TX, United States, 77598
Owner or operator: Ansh Labs, LLC (10041690)
Roles: Manufacturer, Manufacturer for export
First device listed: August 21, 2012
Registered through: 2026
Brand names listed: AMH, AnshCheck Controls, C-Peptide, Estriol, FSH, Glucagon, IGF-1, Inhibin A and more

Devices it lists

Device	Product code	Class	Role	Source
Anti-Müllerian Hormone Test System	PQO	2	Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Inhibin-A	NDR	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Menopause Test System	QDH	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estriol	CGI	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Glucagon	JME	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 24, 2018	DEN180004	picoAMH ELISA	QDH	Unknown	Ansh Labs, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 18, 2020	87057	Class II	Terminated	AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL,	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.	accessdata.fda.gov

Compare with other makers

Updated October 24, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.