FDA.reportPublic FDA data

Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA

Primary DI
00853592008301
Brand
Ansh Labs Dried Blood Spot (DBS) Prolactin ELISA
Company
Ansh Labs, LLC
Model
AL-1016-i
Catalog number
AL-1016-i
Device description
The Prolactin (DBS) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human dried blood spot. This assay 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

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853592008301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853592008301008535920083018535920083010853592008301

GMDN Terms#

Term, Definition table
TermDefinition
Prolactin 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 prolactin 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
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
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
00853592008073Ansh Labs Inhibin A ELISAAL-123-iAL-123-i2021-06-02