Pregnenolone ELISA 11-PRNHU-E01

GUDID B24211PRNHUE010

Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Pregnenolone IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB24211PRNHUE010
NIH Device Record Key17332f19-e5ba-4e3f-bbae-1a16ab9b6c14
Commercial Distribution StatusIn Commercial Distribution
Brand NamePregnenolone ELISA
Version Model Number11-PRNHU-E01
Catalog Number11-PRNHU-E01
Company DUNS784143778
Company NameAMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com
Phone8005925726
Emailcs@alpco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB24211PRNHUE010 [Primary]

FDA Product Code

JNGRadioimmunoassay, Pregnenolone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-02
Device Publish Date2023-05-25

On-Brand Devices [Pregnenolone ELISA]

B24211PREHUE010Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using h
B24211PRNHUE010Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using h

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