Dehydroepiandrosterone Sulfate (DHEA-S) ELISA

GUDID 04049016140368

EUROIMMUN Medizinische Labordiagnostika AG

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016140368
NIH Device Record Keye3f22a8b-b635-4482-ab81-caafdb634ff0
Commercial Distribution Discontinuation2025-06-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDehydroepiandrosterone Sulfate (DHEA-S) ELISA
Version Model NumberEQ 6155-9601
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
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 Perscriptionfalse
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016140368 [Primary]

FDA Product Code

JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-30
Device Publish Date2022-12-08

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

04049016137986 - EUROLabWorkstation IFA2025-06-30
04049016140368 - Dehydroepiandrosterone Sulfate (DHEA-S) ELISA2025-06-30
04049016140368 - Dehydroepiandrosterone Sulfate (DHEA-S) ELISA2025-06-30
04049016147602 - Free Estriol ELISA2025-06-30
04049016152088 - TITERPLANE set for the incubation of slides with 50 fields2025-06-10
04049016152040 - WASH REAGENT 22025-05-21
04049016151876 - Sample buffer 2, Crithidia luciliae sensitive (IFA)2025-03-14
04049016151890 - Sample buffer 2, Crithidia luciliae sensitive (IFA)2025-03-14
04049016151920 - PBS-Tween (IFA)2025-03-12

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