FDA.reportPublic FDA data

Schistosoma IgG ELISA

Primary DI
04048474035124
Brand
Schistosoma IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3512
Catalog number
EIA-3512
Device description
For the qualitative determination of serum or plasma antibodies in humans, primarily IgG, to Schistosoma spp. using the ELISA technique.
Published
2023-08-29
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
GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNHAntigen, Fluorescent Antibody Test, Schistosoma MansoniMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474035124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474035124040484740351244048474035124

GMDN Terms#

Term, Definition table
TermDefinition
Schistosoma mansoni immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to the parasitic flatworm Schistosoma mansoni in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTISCHG04100NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
ENTISCHG0410NovaLisa Schistosoma mansoni IgGGold Standard Diagnostics Frankfurt GmbHGNH2024-08-26
00894175000114AccuDiag ™Diagnostic Automation, Inc.GNH2024-03-06
04048474038729Schistosoma mansoni IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNH2023-08-31
00840239038722Schistosoma mansoni IgG ELISADRG International IncGNH2023-08-25
04049016135449Anti-Schistosoma ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2022-12-08
07640158219607Schistosoma mansoni IgG ELISABordier affinity products S.A.GNH2022-08-09
00840239035127Schistosoma IgG ELISADRG International IncGNH2021-06-07
04049016101727Anti-Schistosoma mansoni IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNH2016-09-24
00813545026455Schistosoma Antibody 96 Tests SCIMEDX CORPORATIONGNH2016-09-21