Home GUDID 00853592008011 Ansh Labs picoPAPP-A ELISA (CE)
Primary DI 00853592008011
Brand Ansh Labs picoPAPP-A ELISA (CE)
Company Ansh Labs, LLC
Model AL-101-i
Catalog number AL-101-i
Device description 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.
Published 2021-06-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00853592008011 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00853592008011 00853592008011 853592008011 0853592008011
GMDN Terms# Term, Definition table Term Definition Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple hormone levels in a clinical specimen using an enzyme immunoassay (EIA) method, in order to predict the risk of trisomy 21 (Down syndrome) as part of a first or second trimester screening assessment. Hormones assayed may include alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), pregnancy associated plasma protein A (PAPP-A), estriol and/or inhibin A.
Regulatory Flags# DUNS number 057752914 Device count 1 DM exempt true Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00853592008042 Ansh Labs PAPP-A2 ELISA AL-109-i AL-109-i 2024-08-12 00853592008059 Ansh Labs Activin A ELISA AL-110-i AL-110-i 2024-08-12 00853592008257 PAPP-A ELISA (CE) AL-106-4-i AL-106-4-i 2024-08-12 00853592008288 Ansh Labs Unconjugated Estriol EIA AL-138-i AL-138-i 2024-08-12 00853592008301 Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA AL-1016-i AL-1016-i 2024-08-12 00853592008318 Ansh Labs DBS Follicle-Stimulating Hormone ELISA AL-187-i AL-187-i 2024-08-12 00853592008325 Ansh Labs DBS Luteinizing Hormone ELISA AL-190-i AL-190-i 2024-08-12 00853592008332 Ansh Labs Ultra-Sensitive Luteinizing Hormone ELISA AL-188 AL-188 2024-08-12 00853592008349 Ansh Labs US Follicle-stimulating Hormone ELISA AL-186 AL-186 2024-08-12 00853592008356 Ansh Labs PECheck(TM) PAPP-A2 ELISA AL-1015-i AL-1015-i 2024-08-12 00853592008363 Ansh Labs PLGF ELISA AL-1008-i AL-1008-i 2024-08-12 00853592008387 Ansh Labs Follistatin ELISA AL-117-i AL-117-i 2024-08-12 00853592008394 Ansh Labs C-Peptide ELISA AL-151-i AL-151-i 2024-08-12 00853592008066 Ansh Labs Total IGF-I ELISA (CE) AL-121-i AL-121-i 2021-06-02 00853592008295 Ansh Labs Total IGF-I ELISA (IVD) AL-121 AL-121 2021-06-02 00853592008103 Ansh Labs AnshCheck AMH Tri-Level Controls AL-CTR-401-i AL-CTR-401-i 2021-06-03 00853592008004 Ansh Labs Ultrasensitive AMH/MIS ELISA AL-105-i AL-105-i 2021-06-02 00853592008028 Ansh Labs PAPP-A ELISA (CE) AL-106-i AL-106-i 2021-06-02 00853592008035 Ansh Labs Inhibin B ELISA (CE) AL-107-i AL-107-i 2021-06-02 00853592008073 Ansh Labs Inhibin A ELISA AL-123-i AL-123-i 2021-06-02
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