FDA.reportPublic FDA data

Influenza Virus A IgG ELISA

Primary DI
00840239037930
Brand
Influenza Virus A IgG ELISA
Company
DRG International Inc
Model
EIA-3793
Catalog number
EIA-3793
Device description
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Published
2023-08-25
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
GNWAntisera, Cf, Influenza Virus A, B, C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNWAntisera, Cf, Influenza Virus A, B, CMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239037930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239037930008402390379308402390379300840239037930

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A virus 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 influenza A virus 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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
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
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIINFG02900NovaLisa Influenza Virus A IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG03000NovaLisa Influenza Virus B IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG0290NovaLisa Influenza Virus A IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG0300NovaLisa Influenza Virus B IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
05032384503070IMAGEN RESPIRATORY SCREEN POS CON SLIDEOXOID LIMITEDGNW2024-07-03
05032384503841IMAGEN Respiratory Screen KitOXOID LIMITEDGNW2024-06-19
04048474037937Influenza Virus A IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGNW2023-08-31
04048474037968Influenza Virus B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2023-08-31
00840239037961Influenza Virus B IgG ELISADRG International IncGNW2023-08-25
B350GSD0130090Influenza A IgG ELISA Test KitGold Standard Diagnostics CorporationGNW2022-12-07
04053252270239Light Diagnostics ™ SimulFluor® Flu A / Flu B ReagentEMD Millipore CorporationGNW2022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control SlidesEMD Millipore CorporationGNW2022-12-01
04053252320439Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-30
04053252368165Light Diagnostics ™ SimulFluor® Flu A/Flu B ReagentEMD Millipore CorporationGNW2022-11-30
04053252473722Light Diagnostics ™ Influenza B Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-30
04053252789229Light Diagnostics ™ Influenza A & B Control SlideEMD Millipore CorporationGNW2022-11-30
04053252330094Light Diagnostics ™ Influenza B Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-29
04053252470226Light Diagnostics ™ Influenza A Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-29
04053252367588Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence AssayEMD Millipore CorporationGNW2022-11-28
08436037124594Light Diagnostics™ Influenza A and B DFA KitEMD Millipore CorporationGNW2022-11-28
B350GSD0130100Influenza B IgG ELISA Test KitGold Standard Diagnostics CorporationGNW2022-10-07
00404847437935Influenza Virus A IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2021-06-07
00404847437966Influenza Virus B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2021-06-07
30014613330288D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330295D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330301D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330318D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330325D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330349D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330356D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07