Dehydroepiandrosterone (DHEA) ELISA 20-DHEHU-E01

GUDID B24220DHEHUE010

The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of dehydroepiandrosterone (DHEA) in human serum and citrate plasma. For in vitro diagnostic use.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)
Primary Device IDB24220DHEHUE010
NIH Device Record Key0ac79295-3e6f-4a2e-8d3e-7a24bac34c3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDehydroepiandrosterone (DHEA) ELISA
Version Model Number20-DHEHU-E01
Catalog Number20-DHEHU-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

Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
Emailcs@alpco.com
Phone800.592.5726
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB24220DHEHUE010 [Primary]

FDA Product Code

JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

On-Brand Devices [Dehydroepiandrosterone (DHEA) ELISA]

B24220DHEHUE010The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of
B24211HEAHUE010The Dehydroepiandrosterone ELISA is intended for the direct quantitative determination of DHEA b

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.