ENA-6-Profile ELISA EIA-3901

GUDID 04048474039016

The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class antibodies against Schistosoma mansoni in human serum or plasma (citrate, heparin).

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474039016
NIH Device Record Key15aa604e-1237-4bb2-bc8e-a9ec40e5ac67
Commercial Distribution StatusIn Commercial Distribution
Brand NameENA-6-Profile ELISA
Version Model NumberEIA-3901
Catalog NumberEIA-3901
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.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
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
GS104048474039016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLLExtractable Antinuclear Antibody, Antigen And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

On-Brand Devices [ENA-6-Profile ELISA]

04048474027808The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of
04048474039016The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class ant
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.