FDA.reportPublic FDA data

Ansh Labs MenoCheck picoAMH ELISA (IVD)

Primary DI
00853592008127
Brand
Ansh Labs MenoCheck picoAMH ELISA (IVD)
Company
Ansh Labs, LLC
Model
AL-124
Catalog number
AL-124
Device description
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.
Published
2021-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853592008127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853592008127008535920081278535920081270853592008127

GMDN Terms#

Term, Definition table
TermDefinition
Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(281) 404-0260TechSupport@AnshLabs.com

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 DIBrandModelCatalogPublished
00853592008042Ansh Labs PAPP-A2 ELISAAL-109-iAL-109-i2024-08-12
00853592008059Ansh Labs Activin A ELISAAL-110-iAL-110-i2024-08-12
00853592008257PAPP-A ELISA (CE)AL-106-4-iAL-106-4-i2024-08-12
00853592008288Ansh Labs Unconjugated Estriol EIAAL-138-iAL-138-i2024-08-12
00853592008301Ansh Labs Dried Blood Spot (DBS) Prolactin ELISAAL-1016-iAL-1016-i2024-08-12
00853592008318Ansh Labs DBS Follicle-Stimulating Hormone ELISAAL-187-iAL-187-i2024-08-12
00853592008325Ansh Labs DBS Luteinizing Hormone ELISAAL-190-iAL-190-i2024-08-12
00853592008332Ansh Labs Ultra-Sensitive Luteinizing Hormone ELISAAL-188AL-1882024-08-12
00853592008349Ansh Labs US Follicle-stimulating Hormone ELISAAL-186AL-1862024-08-12
00853592008356Ansh Labs PECheck(TM) PAPP-A2 ELISAAL-1015-iAL-1015-i2024-08-12
00853592008363Ansh Labs PLGF ELISAAL-1008-iAL-1008-i2024-08-12
00853592008387Ansh Labs Follistatin ELISAAL-117-iAL-117-i2024-08-12
00853592008394Ansh Labs C-Peptide ELISAAL-151-iAL-151-i2024-08-12
00853592008066 Ansh Labs Total IGF-I ELISA (CE)AL-121-iAL-121-i2021-06-02
00853592008295Ansh Labs Total IGF-I ELISA (IVD)AL-121AL-1212021-06-02
00853592008103Ansh Labs AnshCheck AMH Tri-Level ControlsAL-CTR-401-iAL-CTR-401-i2021-06-03
00853592008004Ansh Labs Ultrasensitive AMH/MIS ELISAAL-105-iAL-105-i2021-06-02
00853592008011Ansh Labs picoPAPP-A ELISA (CE)AL-101-iAL-101-i2021-06-02
00853592008028Ansh Labs PAPP-A ELISA (CE)AL-106-iAL-106-i2021-06-02
00853592008035Ansh Labs Inhibin B ELISA (CE)AL-107-iAL-107-i2021-06-02