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ANSH LABS, LLC

Matched from indexed company URL: Ansh Labs, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30081988073008198807ANSH LABS, LLC1N2026-01-01445 Medical Center Blvd Webster TX US 77598

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00853592008042Ansh Labs PAPP-A2 ELISA - The PAPP-A2 enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A2 in human serum and other biological fluids.281-404-0260TECHSUPPORT@ANSHLABS.COM
00853592008059Ansh Labs Activin A ELISA - The Activin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Activin A in human serum and other biological fluids. This assay is intended for in vitro diagnostic use.281-404-0260TECHSUPPORT@ANSHLABS.COM
00853592008257PAPP-A ELISA (CE) - The PAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in serum and other biological fluids. This kit is intended for in vitro diagnostic use.281-404-0260TECHSUPPORT@ANSHLABS.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1447231545539224DEN180004picoAMH ELISAQDH2018-10-24
1447231366794677
1447231504722269
1447231523231193
1447231558076492
1447231573879109
1447231701469839
1447231060291574
1447231220336971
1447231604448072
1447231698156265
1447231994900687

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QDH22018-10-24

GUDID#

Ansh Labs Unconjugated Estriol EIA - The Unconjugated Estriol (uE3) Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated estriol in serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Down syndrome (Trisomy 21) screening in the 2nd trimester using combined biochemical and ultrasound markers may be assessed with appropriate risk calculation software.1,2 It is strongly recommended to use validated software (CE marked) designated specifically for evaluating the risk of Trisomy 21 using uE3 in combination with AFP, hCG, and Inhibin A measurements.

Ansh Labs, LLC

2024-08-12

Ansh Labs Inhibin A ELISA - The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Down syndrome (Trisomy 21) screening in the 2nd trimester using combined biochemical and ultrasound markers may be assessed with appropriate risk calculation software.1,2 It is strongly recommended to use validated software (CE marked) designated specifically for evaluating the risk of Trisomy 21 using Inhibin A in combination with hAFP, hCG, and uE3 measurements.

Ansh Labs, LLC

2021-06-02

Ansh Labs MenoCheck picoAMH ELISA (IVD) - The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only.

Ansh Labs, LLC

2021-06-02