FDA.reportPublic FDA data

Pregnenolone ELISA

Primary DI
B24211PRNHUE010
Brand
Pregnenolone ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
11-PRNHU-E01
Catalog number
11-PRNHU-E01
Device description
Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use.
Published
2023-05-25
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
B24211PRNHUE010PrimaryHIBCC0

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
8005925726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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B24280EZDEV21000Unfilled Easy 2 Stool Extraction Device80-EXDEV2-10080-EXDEV2-1002026-02-02
B24280EZEX21000Easy 2 Stool Extraction Device80-EZEX2-10080-EZEX2-1002025-10-30
B24280CALPHUCH500ALPCO Calprotectin Chemiluminescence ELISA80-CALPHU-CH5080-CALPHU-CH502019-11-04
B24224MABHUE010Microalbumin ELISA24-MABHU-E0124-MABHU-E012018-01-16
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control Set80-LACHU-FCSET2025-06-06
B24280PANHUFCSET0Pancreatic Elastase CLIA Re-Calibrator and Control Set80-PANHU-FCSET2025-06-06
B24225TT4HUE010Total Thyroxine ELISA (Total T4 ELISA)25-TT4HU-E0125-TT4HU-E012017-08-03
B24211PREHUE010Pregnenolone ELISA11-PREHU-E0111-PREHU-E012020-09-25
B24280PANHUCH500Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH5080-PANHU-CH502022-09-09
B24280LACHUFC1000ALPCO Lactoferrin CLIA Kit80-LACHU-FC10080-LACHU-FC1002025-03-03
B24211HGHHUE010Human Growth Hormone ELISA11-HGHHU-E0111-HGHHU-E012025-01-20
B24280PANHUFC1000ALPCO Pancreatic Elastase CLIA80-PANHU-FC10080-PANHU-FC1002024-07-25
B24280PANHUCH010Pancreatic Elastase Chemiluminescence ELISA80-PANHU-CH0180-PANHU-CH012022-09-09
B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
B24220TT3HUE011Total Triiodothyronine (Total T3) ELISA20-TT3HU-E0120-TT3HU-E012024-07-22
B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
B24280CALPHUITCAL0Calprotectin Immunoturbidimetric Assay - Calibrators80-CALPHU-ITCAL80-CALPHU-ITCAL2023-08-18
B24280CALPHUITCON0ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-ITCON80-CALPHU-ITCON2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474049121Pregnenolone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJNG2023-08-31
B652IB59107Pregnenolone ELISAIBL AmericaJNG2023-06-08
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