Ansh Labs, LLC
Webster, TX, US
ANSH LABS, LLC appears in FDA device records in Webster, TX. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Ansh Labs, LLC in 2018.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008198807 | 3008198807 | ANSH LABS, LLC | 445 Medical Center Blvd, Webster, TX 77598 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PQOAnti-Müllerian Hormone Test System
- NDREnzyme Immunoassay, Inhibin-A
- QDHMenopause Test System
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- JMERadioimmunoassay, Glucagon
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0842-2021 | 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, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain