FDA.reportPublic FDA data

Ansh Labs DBS Luteinizing Hormone ELISA

Primary DI
00853592008325
Brand
Ansh Labs DBS Luteinizing Hormone ELISA
Company
Ansh Labs, LLC
Model
AL-190-i
Catalog number
AL-190-i
Device description
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.
Published
2024-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853592008325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853592008325008535920083258535920083250853592008325

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057752914
Device count
1
Kit
true
Lot or batch
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
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
00853592008073Ansh Labs Inhibin A ELISAAL-123-iAL-123-i2021-06-02