Primary Device ID | 00853592008103 |
NIH Device Record Key | 33c433ef-7f01-4940-82e4-0d6112a6f0c0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ansh Labs AnshCheck AMH Tri-Level Controls |
Version Model Number | AL-CTR-401-i |
Catalog Number | AL-CTR-401-i |
Company DUNS | 057752914 |
Company Name | Ansh Labs, LLC |
Device Count | 1 |
DM Exempt | true |
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 | true |
Expiration Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853592008103 [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 | 2021-06-11 |
Device Publish Date | 2021-06-03 |
00853592008103 - Ansh Labs AnshCheck AMH Tri-Level Controls | 2021-06-11Ansh 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. |
00853592008103 - Ansh Labs AnshCheck AMH Tri-Level Controls | 2021-06-11 Ansh Labs AMH Tri-Level Controls are intended for use as assay quality controls to monitor the precision and reproducibility of |
00853592008004 - Ansh Labs Ultrasensitive AMH/MIS ELISA | 2021-06-10 The Ultra-Sensitive Anti-Müllerian hormone/ Müllerian inhibiting substance (US AMH/MIS) enzyme linked immunuosorbent assay (EL |
00853592008011 - Ansh Labs picoPAPP-A ELISA (CE) | 2021-06-10 The picoPAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in hu |
00853592008028 - Ansh Labs PAPP-A ELISA (CE) | 2021-06-10 The PAPP-A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A in serum |
00853592008035 - Ansh Labs Inhibin B ELISA (CE) | 2021-06-10 The Inhibin B enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Inhibin B in |
00853592008066 - Ansh Labs Total IGF-I ELISA (CE) | 2021-06-10 The Total IGF-I enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of IGF-I in se |
00853592008073 - Ansh Labs Inhibin A ELISA | 2021-06-10 The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhib |
00853592008080 - Ansh Labs picoAMH ELISA | 2021-06-10 The picoAMH ELISA is an enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of anti-Müllerian hormone (A |