| Primary Device ID | 00853592008318 |
| NIH Device Record Key | 85e3eb8e-236c-4447-8655-65505ffa7e07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ansh Labs DBS Follicle-Stimulating Hormone ELISA |
| Version Model Number | AL-187-i |
| Catalog Number | AL-187-i |
| Company DUNS | 057752914 |
| Company Name | Ansh Labs, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM | |
| Phone | 281-404-0260 |
| TECHSUPPORT@ANSHLABS.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853592008318 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-20 |
| Device Publish Date | 2024-08-12 |
| 00853592008042 - Ansh Labs PAPP-A2 ELISA | 2024-08-20 The PAPP-A2 enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A2 in huma |
| 00853592008059 - Ansh Labs Activin A ELISA | 2024-08-20 The Activin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Activin A in |
| 00853592008257 - PAPP-A ELISA (CE) | 2024-08-20 The PAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in serum |
| 00853592008288 - Ansh Labs Unconjugated Estriol EIA | 2024-08-20 The Unconjugated Estriol (uE3) Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated |
| 00853592008301 - Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA | 2024-08-20 The Prolactin (DBS) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolact |
| 00853592008318 - Ansh Labs DBS Follicle-Stimulating Hormone ELISA | 2024-08-20The 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. |
| 00853592008318 - Ansh Labs DBS Follicle-Stimulating Hormone ELISA | 2024-08-20 The Dried Blood Spot Follicle-Stimulating Hormone (FSH) immunosorbent assay (ELISA) kit provides materials for the quantitative |
| 00853592008325 - Ansh Labs DBS Luteinizing Hormone ELISA | 2024-08-20 The Dried Blood Spot Luteinizing hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measuremen |
| 00853592008332 - Ansh Labs Ultra-Sensitive Luteinizing Hormone ELISA | 2024-08-20 The Ultra-Sensitive Luteinizing Hormone (LH) immunosorbent assay (ELISA) kit provides materials for the quantitative measurement |