FDA.reportPublic FDA data

Pregnenolone ELISA

Primary DI
B652IB59107
Brand
Pregnenolone ELISA
Company
IBL America
Model
IB59107
Catalog number
IB59107
Device description
For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).
Published
2023-06-08
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#

Product Codes#

Code, Name table
CodeName
JNGRadioimmunoassay, Pregnenolone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNGRadioimmunoassay, PregnenoloneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B652IB59107PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pregnenolone 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 pregnenolone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as an aid in the diagnosis of adrenal hyperplasia and hirsutism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-523-1246info@ibl-america.com

Regulatory Flags#

DUNS number
159853449
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B652IB59105Estrone ELISAIB59105IB591052023-06-08
B652IB59109Testosterone (Free) ELISAIB591092023-06-08
B652IB59110Prolactin ELISAIB59110IB591102023-06-08
B652IB59134Total Estrogens ELISAIB591342023-06-08
B652IB793050Salivary Cortisol ELISAIB793052018-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474049121Pregnenolone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJNG2023-08-31
B24211PRNHUE010Pregnenolone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNG2023-05-25
04049016140849Pregnenolone ELISAEUROIMMUN Medizinische Labordiagnostika AGJNG2022-12-08
B261CANPRE4500N0DBC Pregnenolone ELISADiagnostics Biochem Canada IncJNG2022-11-15
B261CANPRE45000DBC Pregnenolone ELISADiagnostics Biochem Canada IncJNG2022-11-10
00840239041708Pregnenolone Direct ELISADRG International IncJNG2021-06-07
00840239049124Pregnenolone ELISADRG International IncJNG2021-06-07
B24211PREHUE010Pregnenolone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JNG2020-09-25