anshlabs.comAnsh 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.
2024-08-12
ANSH LABS, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008198807 | 3008198807 | ANSH LABS, LLC | 1 | N | 2026-01-01 | 445 Medical Center Blvd Webster TX US 77598 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00853592008042 | Ansh 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. | 281-404-0260 | TECHSUPPORT@ANSHLABS.COM |
| 00853592008059 | Ansh 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. | 281-404-0260 | TECHSUPPORT@ANSHLABS.COM |
| 00853592008257 | PAPP-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. | 281-404-0260 | TECHSUPPORT@ANSHLABS.COM |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 144723 | 1545539224 | DEN180004 | picoAMH ELISA | QDH | 2018-10-24 |
| 144723 | 1366794677 | ||||
| 144723 | 1504722269 | ||||
| 144723 | 1523231193 | ||||
| 144723 | 1558076492 | ||||
| 144723 | 1573879109 | ||||
| 144723 | 1701469839 | ||||
| 144723 | 1060291574 | ||||
| 144723 | 1220336971 | ||||
| 144723 | 1604448072 | ||||
| 144723 | 1698156265 | ||||
| 144723 | 1994900687 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QDH | 2 | 2018-10-24 |
GUDID#
Ansh 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.
2024-08-12
PAPP-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.
2024-08-12
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.
2024-08-12
Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA - The Prolactin (DBS) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human dried blood spot. This assay is intended for in vitro diagnostic use.
2024-08-12
Ansh Labs DBS Follicle-Stimulating Hormone ELISA - The Dried Blood Spot Follicle-Stimulating Hormone (FSH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Follicle-stimulating hormone (FSH). It is intended for in vitro diagnostic use.
2024-08-12
Ansh Labs DBS Luteinizing Hormone ELISA - The Dried Blood Spot Luteinizing hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Luteinizing hormone (LH). It is intended for in vitro diagnostic use.
2024-08-12
Ansh Labs Ultra-Sensitive Luteinizing Hormone ELISA - The Ultra-Sensitive Luteinizing Hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Luteinizing Hormone (LH), in human serum. It is intended for research use only as a diagnosis tool for monitoring of various hormonal reproductive disorders.
2024-08-12
Ansh Labs US Follicle-stimulating Hormone ELISA - The US Follicle-stimulating hormone (FSH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Follicle-stimulating hormone (FSH) in serum and plasma. It is intended for research use only.
2024-08-12
Ansh Labs PECheck(TM) PAPP-A2 ELISA - The PECheckTM PAPP-A2 Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A2 in human maternal serum and other biological fluids. The kit is intended for in vitro diagnostic use.
2024-08-12
Ansh Labs PLGF ELISA - The PLGF enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PLGF in serum and other biological fluids. This kit is intended for in vitro diagnostic use.
2024-08-12
Ansh Labs Follistatin ELISA - The Follistatin enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of follistatin in human serum and other biological fluids. This kit is intended for in-vitro diagnostic use.
2024-08-12
Ansh Labs C-Peptide ELISA - The C-Peptide of Insulin Enzyme-Linked Immunosorbent (ELISA) Kit provides materials for the quantitative measurement of C-peptide of insulin in human serum and plasma. This kit is intended for in vitro diagnostic use.
2024-08-12
Ansh Labs Total IGF-I ELISA (CE) - The Total IGF-I enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of IGF-I in serum, plasma and other biological fluids. This assay is intended for in vitro diagnostic use only.
2021-06-02
Ansh Labs Total IGF-I ELISA (IVD) - The Total IGF-I enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of IGF-I in serum, plasma and other biological fluids. This assay is intended for in vitro Diagnostic Use Only.
2021-06-02
Ansh Labs AnshCheck AMH Tri-Level Controls - Ansh Labs AMH Tri-Level Controls are intended for use as assay quality controls to monitor the precision and reproducibility of laboratory testing methods for the determination of AMH in serum, plasma or other biological fluids. Tri-level controls are run as unknowns against kit calibrators in any human AMH assays.
2021-06-03
Ansh Labs Ultrasensitive AMH/MIS ELISA - The Ultra-Sensitive Anti-Müllerian hormone/ Müllerian inhibiting substance (US AMH/MIS) enzyme linked immunuosorbent assay (ELISA) kit provides materials for the quantitative measurement of AMH/MIS in human serum, plasma and other biological fluids. This assay is intended for in vitro diagnostic use only.
2021-06-02
Ansh Labs picoPAPP-A ELISA (CE) - The picoPAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in human serum and other biological fluids. This assay is intended for in vitro diagnostic use.
2021-06-02
Ansh Labs PAPP-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 assay is intended for in vitro diagnostic use.
2021-06-02
Ansh Labs Inhibin B ELISA (CE) - The Inhibin B enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Inhibin B in human serum and other biological fluids. This assay is intended for in vitro diagnostic use
2021-06-02
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.
2021-06-02
Ansh Labs picoAMH ELISA - The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum, Li-Heparin and K2 EDTA plasma. It is intended to be used as an aid in the determination of ovarian status in women in reproductive age and during menopausal transition. It is intended for in vitro diagnostic use.
2021-06-02
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.
2021-06-02
Ansh Labs Glycosylated Fibronectin ELISA - Glycosylated Fibronectin enzyme linked immunoassay (ELISA) kit provides the materials for the quantitative measurement of GlyFn in human maternal serum. This assay is intended for in vitro diagnostic use.
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.
2021-06-02
Ansh Labs Dried Blood Spot (DBS) AMH ELISA - The Anti-Müllerian hormone (DBS AMH) enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of AMH in human dried blood spot. This kit is intended for in-vitro diagnostic use only.
2021-06-02
Ansh Labs Ultrasensitive Inhibin B ELISA - The US Inhibin B enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Inhibin B in human serum and other biological fluids. This assay is intended for in vitro diagnostic use.
2021-06-02
Ansh Labs PCOCheck ELISA - The PCOCheck ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (AMH) in human serum, Li-Heparin and K2 EDTA plasma. This assay is not impacted by AMH post translational modifications. It is intended to be used as an aid in the determination of ovarian reserve, and stratification of women with polycystic ovarian morphology (PCOM). This assay is intended for in vitro diagnostic use.
2021-06-02
Ansh Labs Prolactin ELISA (IVD) - Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
2021-06-02
Ansh Labs Prolactin ELISA (CE) - Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
2021-06-02
Ansh Labs Unconjugated Estriol EIA - The Unconjugated Estriol Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated estriol in serum. This assay is intended for in vitro Diagnostic Use Only. The test may help aid in the diagnosis and treatment of fetoplacental distress.
2021-06-02
Ansh Labs Glucagon ELISA - The Glucagon Enzyme Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Glucagon in human plasma and other biological fluids. This assay is intended for in vitro diagnostic use.
2021-06-01
Ansh Labs Glucagon ELISA - The Glucagon Enzyme Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Glucagon in human plasma and other biological fluids. This assay is intended for in vitro diagnostic use.
2021-06-01